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Radiation Therapy With or Without Combination Chemotherapy or Pazopanib Before Surgery in Treating Patients With Newly Diagnosed Non-rhabdomyosarcoma Soft Tissue Sarcomas That Can Be Removed by Surgery

Primary Purpose

Alveolar Soft Part Sarcoma, Angiomatoid Fibrous Histiocytoma, Atypical Fibroxanthoma

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Doxorubicin
Doxorubicin Hydrochloride
Ifosfamide
Pazopanib
Pazopanib Hydrochloride
Radiation Therapy
Therapeutic Conventional Surgery
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alveolar Soft Part Sarcoma

Eligibility Criteria

2 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Note: eligible patients must have a body surface area >= 0.5 m^2 AND be able to swallow whole tablets

  • Newly diagnosed and histopathologically confirmed, potentially resectable NRSTS of the extremity and trunk will be eligible for the chemotherapy or non-chemotherapy cohort based on:

    • Evidence of chemotherapy sensitivity of the histologic sarcoma subtype based on existing evidence from prior clinical trials
    • Sufficient risk of metastatic disease to warrant chemotherapy based on size and grade and
    • Medically deemed able or unable to undergo chemotherapy
    • Notes: an incisional biopsy or core biopsy is preferred; fine needle aspiration biopsy is not acceptable to establish the diagnosis

  • ELIGIBLE SITES:

    • Extremities: upper (including shoulder) and lower (including hip)
    • Trunk: body wall
  • INELIGIBLE SITES: Head and neck, visceral organs (with the exception of embryonal sarcoma of the liver), retroperitoneum, peritoneum, pelvis within the confines of the bony pelvis
  • ELIGIBILITY FOR CHEMOTHERAPY COHORT:
  • Stage T2a/b (> 5 cm) and grade 2 or 3 AND

  • One of the following chemosensitive histologies as defined in the World Health Organization (WHO) classification of soft tissue tumors (with some evidence of good response to chemoradiation and of sufficient high risk of metastases, or clear evidence of metastases):

    • Unclassified soft tissue sarcomas that are too undifferentiated to be placed in a specific pathologic category in the WHO classification (often called "undifferentiated soft tissue sarcoma" or "soft tissue sarcoma not otherwise specified [NOS]")
    • Synovial sarcoma
    • Angiosarcoma of soft tissue
    • Adult fibrosarcoma
    • Mesenchymal (extraskeletal) chondrosarcoma
    • Leiomyosarcoma
    • Liposarcoma (excluding myxoid liposarcoma)
    • Undifferentiated pleomorphic sarcoma
    • Embryonal sarcoma of the liver
  • Patients meeting the above criteria (histology, size, and grade) with the EXCEPTION of histologies noted above may enroll on the chemotherapy cohort or the non-chemotherapy cohort at the discretion of the enrolling investigator; patients meeting these criteria with the EXCEPTION of histologies noted above but medically deemed unable to receive chemotherapy or who elect not to receive chemotherapy are eligible for the non-chemotherapy cohort

  • Patients with the following histologies are only eligible for the chemotherapy cohort and cannot enroll on the non-chemotherapy cohort:

    • Unclassified soft tissue sarcomas that are too undifferentiated to be placed in a specific pathologic category in the WHO classification (often called "undifferentiated soft tissue sarcoma" or "soft tissue sarcoma NOS") in patients < 30 years of age
    • Synovial sarcoma
    • Embryonal sarcoma of the liver
  • ELIGIBILITY FOR NON-CHEMOTHERAPY COHORT:

  • Patients with any size of grade 2 or 3 of the following "intermediate (rarely metastasizing)" or "malignant" tumors, as defined in the WHO classification of soft tissue tumors for which we have consensus data of chemotherapy-resistance are eligible only for the non-chemotherapy cohort:

    • So-called fibrohistiocytic tumors - plexiform fibrohistiocytic tumor, giant cell tumor of soft tissues
    • Fibroblastic/myofibroblastic tumors - solitary fibrous tumor, malignant solitary fibrous tumor, inflammatory myofibroblastic tumor, low grade myofibroblastic sarcoma, myxoinflammatory fibroblastic sarcoma, atypical myxoinflammatory fibroblastic tumor, myxofibrosarcoma, low grade fibromyxoid sarcoma, sclerosing epithelioid fibrosarcoma
    • Tumors of uncertain differentiation - epithelioid sarcoma, alveolar soft part sarcoma, clear cell sarcoma of soft tissue, angiomatoid fibrous histiocytoma, ossifying fibromyxoid tumor, myoepithelioma, myoepithelial carcinoma, extraskeletal myxoid chondrosarcoma, neoplasms with perivascular epithelioid cell differentiation (PEComa), intimal sarcoma, atypical fibroxanthoma, mixed tumor NOS, phosphaturic mesenchymal tumor, malignant ossifying fibromyxoid tumor, malignant mixed tumor, malignant phosphaturic mesenchymal tumor
    • Chondro-osseous tumors - extraskeletal osteosarcoma
    • Pericytic (perivascular) tumors - malignant glomus tumor
    • Nerve sheath tumors - malignant peripheral nerve sheath tumor, malignant granular cell tumor, epithelioid malignant peripheral nerve sheath tumor, malignant Triton tumor
    • Undifferentiated sarcomas (with a specific pathologic category in the WHO classification) - undifferentiated round cell sarcoma, undifferentiated epithelioid sarcoma, undifferentiated spindle cell sarcoma
  • Patients meeting the criteria (histology, size, and grade) with the EXCEPTION of histologies noted above may enroll on the non-chemotherapy cohort at the discretion of the enrolling investigator; patients meeting these criteria with the EXCEPTION of histologies noted above but medically deemed unable to receive chemotherapy or who elect not to receive chemotherapy are eligible for the non-chemotherapy cohort; note that tumors arising in bone are NOT eligible for this study

  • Extent of disease:

    • Patients with non-metastatic and metastatic disease are eligible
    • Initially unresectable patients, with or without metastatic disease, are eligible as long as there is a commitment at enrollment to resect the primary tumor
  • Sufficient tissue and blood must be available to submit for required biology studies
  • Lansky performance status score >= 70 for patients =< 16 years of age
  • Karnofsky performance status score >= 70 for patients > 16 years of age
  • Absolute neutrophil count >= 1500/uL; Note: no transfusions are permitted 7 days prior to laboratory studies to determine eligibility
  • Platelet count >= 100,000/uL; Note: no transfusions are permitted 7 days prior to laboratory studies to determine eligibility
  • Hemoglobin >= 8 g/dL for patients =< 16 years of age; >= 9 g/dL for patients > 16 years of age; Note: no transfusions are permitted 7 days prior to laboratory studies to determine eligibility

  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or normal serum creatinine based on age/gender as follows:

    • 2 to < 6 years; 0.8 mg/dL male; 0.8 mg/dL female
    • 6 to < 10 years; 1 mg/dL male; 1 mg/dL female
    • 10 to < 13 years; 1.2 mg/dL male; 1.2 mg/dL female
    • 13 to < 16 years; 1.5 mg/dL male; 1.4 mg/dL female
    • >= 16 years; 1.5 mg/dL male; 1.4 mg/dL female
  • Total bilirubin =< 1.5 x upper limit of normal (ULN) for age
  • Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x upper limit of normal (ULN) for age
  • Shortening fraction of >= 27% by echocardiogram OR ejection fraction of >= 50% by radionuclide angiogram
  • Corrected QT interval (QTc) < 480 msec
  • No evidence of dyspnea at rest, no exercise intolerance, and a resting pulse oximetry reading > 94% on room air if there is clinical indication for determination
  • Patients on low molecular weight heparin or Coumadin (with a stable international normalized ratio [INR]) are eligible
  • Patient must have a life expectancy of at least 3 months with appropriate therapy
  • All patients and/or their parents or legal guardians must sign a written informed consent
  • All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Exclusion Criteria:

  • Patients with grade 1 NRSTS tumors of any size are not eligible
  • Patients with known central nervous system (CNS) metastases are not eligible; Note: brain imaging is not an eligibility requirement
  • Patients with evidence of active bleeding or bleeding diathesis will be excluded (Note: patients aged > 17 years with excess of 2.5 mL of hemoptysis are not eligible)
  • Patients with gross total resection of the primary tumor prior to enrollment on ARST1321 are NOT eligible; patients who have experienced tumor recurrence after a gross total tumor resection are NOT eligible

  • Patients with uncontrolled hypertension are ineligible; uncontrolled hypertension is defined as follows:

    • Patients aged =< 17 years: greater than 95th percentile systolic and diastolic blood pressure based on age and height which is not controlled by one anti-hypertensive medication
    • Patients aged > 17 years: systolic blood pressure >= 140 mmHg and/or diastolic blood pressure >= 90 mmHg that is not controlled by one anti-hypertensive medication

  • Prior Therapy:

    • Patients must have had no prior anthracycline (e.g., doxorubicin, daunorubicin) or ifosfamide chemotherapy
    • Patients must have had no prior use of pazopanib or similar multi-targeted tyrosine kinase inhibitors (TKI)
    • Patients must have had no prior radiotherapy to tumor-involved sites
    • Note: patients previously treated for a non-NRSTS cancer are eligible provided they meet the prior therapy requirements; patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier are excluded
  • Other types of invasive malignancy that are not disease free within 3 years except for non-melanoma skin cancer, lentigo maligna, any carcinoma-in-situ or prostate cancer with low risk factors
  • CYTOCHROME P450 3A4 (CYP3A4) substrates WITH narrow therapeutic indices: patients chronically receiving medications known to be metabolized by CYP3A4 and with narrow therapeutic indices within 7 days prior to study enrollment, including but not limited to pimozide, aripiprazole, triazolam, ergotamine and halofantrine are not eligible; Note: the use of fentanyl is permitted
  • CYP3A4 Inhibitors: patients chronically receiving drugs that are known potent CYP3A4 inhibitors within 7 days prior to study enrollment, including but not limited to itraconazole, clarithromycin, erythromycin many non-nucleoside reverse-transcriptase inhibitors (NNRTIs), diltiazem, verapamil, and grapefruit juice are not eligible
  • CYP3A4 Inducers: patients chronically receiving drugs that are known potent CYP3A4 inducers within 14 days prior to study enrollment, including but not limited to carbamazepine, phenobarbital, phenytoin, rifampin, and St. John's wort are not eligible (with the exception of glucocorticoids)
  • Certain medications that are associated with a risk for QTc prolongation and/or Torsades de Pointes, although not prohibited, should be avoided or replaced with medications that do not carry these risks, if possible

  • Subjects with any condition that may impair the ability to swallow or absorb oral medications/investigational product including:

    • Any lesion, whether induced by tumor, radiation or other conditions, which makes it difficult to swallow capsules or pills
    • Prior surgical procedures affecting absorption including, but not limited to major resection of stomach or small bowel
    • Active peptic ulcer disease
    • Malabsorption syndrome

  • Subjects with any condition that may increase the risk of gastrointestinal bleeding or gastrointestinal perforation, including:

    • Active peptic ulcer disease
    • Known intraluminal metastatic lesions
    • Inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease) or other gastrointestinal conditions which increase the risk of perforation
    • History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days prior to beginning study treatment

  • Subjects with any of the following cardiovascular conditions within the past 6 months

    • Cerebrovascular accident (CVA) or transient ischemic attack (TIA)
    • Cardiac arrhythmia
    • Admission for unstable angina
    • Cardiac angioplasty or stenting
    • Coronary artery bypass graft surgery
    • Pulmonary embolism, untreated deep venous thrombosis (DVT) or DVT which has been treated with therapeutic anticoagulation for less than 6 weeks
    • Arterial thrombosis
    • Symptomatic peripheral vascular disease
    • Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system; a subject who has a history of class II heart failure and is asymptomatic on treatment may be considered eligible
  • History of serious or non-healing wound, ulcer, or bone fracture
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
  • Patients who are unable to swallow whole tablets are not eligible
  • Patients with a body surface area < 0.5 m^2 are not eligible
  • Human immunodeficiency virus (HIV)-positive subjects on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with pazopanib; in addition, these subjects are at increased risk of lethal infections when treated with marrow-suppressive therapy
  • Patients who are receiving any other investigational agent(s)

  • Pregnancy and breast feeding:

    • Female patients who are pregnant are ineligible due to risks of fetal and teratogenic adverse events as seen in animal/human studies
    • Lactating females are not eligible unless they have agreed not to breastfeed their infants during treatment and for a period of 1 month following completion of treatment
    • Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained
  • Unwillingness to use an effective contraceptive method for the duration of their study participation and for at least 1 month after treatment is completed if sexually active with reproductive potential

Sites / Locations

  • Children's Hospital of Alabama
  • University of Alabama at Birmingham Cancer Center
  • The Kirklin Clinic at Acton Road
  • Anchorage Associates in Radiation Medicine
  • Alaska Breast Care and Surgery LLC
  • Alaska Oncology and Hematology LLC
  • Alaska Women's Cancer Care
  • Anchorage Oncology Centre
  • Katmai Oncology Group
  • Providence Alaska Medical Center
  • Banner Children's at Desert
  • Phoenix Childrens Hospital
  • Banner University Medical Center - Tucson
  • Arkansas Children's Hospital
  • Kaiser Permanente-Anaheim
  • AIS Cancer Center at San Joaquin Community Hospital
  • Providence Saint Joseph Medical Center/Disney Family Cancer Center
  • Kaiser Permanente Downey Medical Center
  • City of Hope Comprehensive Cancer Center
  • Loma Linda University Medical Center
  • Miller Children's and Women's Hospital Long Beach
  • Children's Hospital Los Angeles
  • Kaiser Permanente Los Angeles Medical Center
  • Los Angeles County-USC Medical Center
  • USC / Norris Comprehensive Cancer Center
  • Cedars Sinai Medical Center
  • UCLA / Jonsson Comprehensive Cancer Center
  • Valley Children's Hospital
  • UCSF Benioff Children's Hospital Oakland
  • Kaiser Permanente-Oakland
  • Children's Hospital of Orange County
  • Lucile Packard Children's Hospital Stanford University
  • Stanford Cancer Institute Palo Alto
  • Kaiser Permanente-Riverside
  • Sutter Medical Center Sacramento
  • University of California Davis Comprehensive Cancer Center
  • Kaiser Permanente-San Diego Zion
  • Rady Children's Hospital - San Diego
  • UCSF Medical Center-Mission Bay
  • Kaiser Permanente-San Marcos
  • Kaiser San Rafael-Gallinas
  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
  • Gene Upshaw Memorial Tahoe Forest Cancer Center
  • Children's Hospital Colorado
  • UCHealth University of Colorado Hospital
  • UCHealth Memorial Hospital Central
  • Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
  • Poudre Valley Hospital
  • Connecticut Children's Medical Center
  • Yale University
  • Alfred I duPont Hospital for Children
  • MedStar Georgetown University Hospital
  • Children's National Medical Center
  • UM Sylvester Comprehensive Cancer Center at Deerfield Beach
  • Golisano Children's Hospital of Southwest Florida
  • University of Florida Health Science Center - Gainesville
  • Memorial Regional Hospital/Joe DiMaggio Children's Hospital
  • Nemours Children's Clinic-Jacksonville
  • University of Miami Miller School of Medicine-Sylvester Cancer Center
  • Nicklaus Children's Hospital
  • AdventHealth Orlando
  • Nemours Children's Hospital
  • Nemours Children's Clinic - Pensacola
  • Johns Hopkins All Children's Hospital
  • Saint Joseph's Hospital/Children's Hospital-Tampa
  • Moffitt Cancer Center
  • Saint Mary's Hospital
  • Emory University Hospital Midtown
  • Children's Healthcare of Atlanta - Egleston
  • Emory University Hospital/Winship Cancer Institute
  • Augusta University Medical Center
  • Memorial Health University Medical Center
  • Straub Clinic and Hospital
  • Kaiser Permanente Moanalua Medical Center
  • Kapiolani Medical Center for Women and Children
  • Saint Luke's Cancer Institute - Boise
  • Saint Luke's Cancer Institute - Fruitland
  • Saint Luke's Cancer Institute - Meridian
  • Saint Luke's Cancer Institute - Nampa
  • Saint Luke's Cancer Institute - Twin Falls
  • Lurie Children's Hospital-Chicago
  • Northwestern University
  • Rush University Medical Center
  • University of Illinois
  • University of Chicago Comprehensive Cancer Center
  • Northwestern Medicine Cancer Center Delnor
  • Loyola University Medical Center
  • Good Samaritan Regional Health Center
  • UC Comprehensive Cancer Center at Silver Cross
  • Advocate Children's Hospital-Oak Lawn
  • Advocate Children's Hospital-Park Ridge
  • Saint Jude Midwest Affiliate
  • Saint John's Hospital
  • Southern Illinois University School of Medicine
  • Memorial Medical Center
  • Northwestern Medicine Cancer Center Warrenville
  • Riley Hospital for Children
  • Ascension Saint Vincent Indianapolis Hospital
  • Reid Health
  • Blank Children's Hospital
  • Iowa Methodist Medical Center
  • Medical Oncology and Hematology Associates-Des Moines
  • Broadlawns Medical Center
  • Iowa Lutheran Hospital
  • University of Iowa/Holden Comprehensive Cancer Center
  • Siouxland Regional Cancer Center
  • Methodist West Hospital
  • Newman Regional Health
  • Central Care Cancer Center - Garden City
  • Saint Catherine Hospital
  • Central Care Cancer Center - Great Bend
  • Saint Rose Ambulatory and Surgery Center
  • HaysMed University of Kansas Health System
  • University of Kansas Cancer Center
  • Olathe Health Cancer Center
  • University of Kansas Cancer Center-Overland Park
  • Ascension Via Christi - Pittsburg
  • Salina Regional Health Center
  • University of Kansas Health System Saint Francis Campus
  • University of Kansas Hospital-Westwood Cancer Center
  • University of Kentucky/Markey Cancer Center
  • Norton Children's Hospital
  • Norton Hospital Pavilion and Medical Campus
  • Norton Suburban Hospital and Medical Campus
  • Children's Hospital New Orleans
  • Ochsner Medical Center Jefferson
  • Eastern Maine Medical Center
  • Maine Children's Cancer Program
  • Sinai Hospital of Baltimore
  • Johns Hopkins University/Sidney Kimmel Cancer Center
  • Walter Reed National Military Medical Center
  • Massachusetts General Hospital Cancer Center
  • Dana-Farber Cancer Institute
  • UMass Memorial Medical Center - University Campus
  • C S Mott Children's Hospital
  • Bronson Battle Creek
  • Henry Ford Cancer Institute-Downriver
  • Henry Ford Macomb Hospital-Clinton Township
  • Wayne State University/Karmanos Cancer Institute
  • Henry Ford Hospital
  • Ascension Saint John Hospital
  • Michigan State University Clinical Center
  • Hurley Medical Center
  • Helen DeVos Children's Hospital at Spectrum Health
  • Spectrum Health at Butterworth Campus
  • Trinity Health Grand Rapids Hospital
  • Allegiance Health
  • Bronson Methodist Hospital
  • West Michigan Cancer Center
  • Borgess Medical Center
  • Sparrow Hospital
  • Trinity Health Muskegon Hospital
  • Lakeland Hospital Niles
  • Spectrum Health Reed City Hospital
  • Beaumont Children's Hospital-Royal Oak
  • Lakeland Medical Center Saint Joseph
  • Marie Yeager Cancer Center
  • Munson Medical Center
  • Henry Ford West Bloomfield Hospital
  • Essentia Health Cancer Center
  • Children's Hospitals and Clinics of Minnesota - Minneapolis
  • University of Minnesota/Masonic Cancer Center
  • Mayo Clinic in Rochester
  • University of Mississippi Medical Center
  • Central Care Cancer Center - Bolivar
  • Columbia Regional
  • Siteman Cancer Center at West County Hospital
  • Freeman Health System
  • Children's Mercy Hospitals and Clinics
  • The University of Kansas Cancer Center-South
  • Research Medical Center
  • University of Kansas Cancer Center - North
  • University of Kansas Cancer Center - Lee's Summit
  • Delbert Day Cancer Institute at PCRMC
  • Mercy Clinic-Rolla-Cancer and Hematology
  • Cardinal Glennon Children's Medical Center
  • Washington University School of Medicine
  • Mercy Hospital Saint Louis
  • Mercy Hospital Springfield
  • CoxHealth South Hospital
  • Children's Hospital and Medical Center of Omaha
  • University of Nebraska Medical Center
  • Radiation Oncology Centers of Nevada Central
  • GenesisCare USA - Las Vegas
  • Alliance for Childhood Diseases/Cure 4 the Kids Foundation
  • Summerlin Hospital Medical Center
  • Comprehensive Cancer Centers of Nevada
  • Renown Regional Medical Center
  • Saint Mary's Regional Medical Center
  • Radiation Oncology Associates
  • Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
  • Hackensack University Medical Center
  • Morristown Medical Center
  • Saint Peter's University Hospital
  • Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
  • Newark Beth Israel Medical Center
  • Saint Joseph's Regional Medical Center
  • University of New Mexico Cancer Center
  • Albany Medical Center
  • Montefiore Medical Center-Einstein Campus
  • Montefiore Medical Center-Weiler Hospital
  • Montefiore Medical Center - Moses Campus
  • Roswell Park Cancer Institute
  • Glens Falls Hospital
  • NYU Winthrop Hospital
  • The Steven and Alexandra Cohen Children's Medical Center of New York
  • Laura and Isaac Perlmutter Cancer Center at NYU Langone
  • Mount Sinai Hospital
  • NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
  • NYP/Weill Cornell Medical Center
  • University of Rochester
  • State University of New York Upstate Medical University
  • New York Medical College
  • Mission Hospital
  • UNC Lineberger Comprehensive Cancer Center
  • Carolinas Medical Center/Levine Cancer Institute
  • Novant Health Presbyterian Medical Center
  • Duke University Medical Center
  • East Carolina University
  • Matthews Radiation Oncology Center
  • Wake Forest University Health Sciences
  • Sanford Broadway Medical Center
  • Children's Hospital Medical Center of Akron
  • UHHS-Chagrin Highlands Medical Center
  • Indu and Raj Soin Medical Center
  • Dayton Physicians LLC-Miami Valley South
  • Miami Valley Hospital South
  • Cincinnati Children's Hospital Medical Center
  • Oncology Hematology Care Inc-Kenwood
  • Oncology Hematology Care Inc-Blue Ash
  • Case Western Reserve University
  • Rainbow Babies and Childrens Hospital
  • Cleveland Clinic Foundation
  • Nationwide Children's Hospital
  • Ohio State University Comprehensive Cancer Center
  • Dayton Children's Hospital
  • Good Samaritan Hospital - Dayton
  • Miami Valley Hospital
  • Dayton Physician LLC-Miami Valley Hospital North
  • Miami Valley Hospital North
  • Armes Family Cancer Center
  • Blanchard Valley Hospital
  • Orion Cancer Care
  • Atrium Medical Center-Middletown Regional Hospital
  • Dayton Physicians LLC-Atrium
  • Dayton Physicians LLC-Wayne
  • Wayne Hospital
  • Greater Dayton Cancer Center
  • Kettering Medical Center
  • Springfield Regional Cancer Center
  • Springfield Regional Medical Center
  • ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
  • Dayton Physicians LLC - Troy
  • Upper Valley Medical Center
  • Wright-Patterson Medical Center
  • University of Oklahoma Health Sciences Center
  • Mercy Hospital Oklahoma City
  • Oklahoma Cancer Specialists and Research Institute-Tulsa
  • Saint Charles Health System
  • Clackamas Radiation Oncology Center
  • Bay Area Hospital
  • Providence Portland Medical Center
  • Providence Saint Vincent Medical Center
  • Legacy Emanuel Children's Hospital
  • Oregon Health and Science University
  • Lehigh Valley Hospital-Cedar Crest
  • Lehigh Valley Hospital - Muhlenberg
  • Geisinger Medical Center
  • Penn State Children's Hospital
  • Drexel University School of Medicine
  • Children's Hospital of Philadelphia
  • Thomas Jefferson University Hospital
  • Fox Chase Cancer Center
  • Saint Christopher's Hospital for Children
  • Allegheny General Hospital
  • Children's Hospital of Pittsburgh of UPMC
  • Lankenau Medical Center
  • Rhode Island Hospital
  • Prisma Health Cancer Institute - Spartanburg
  • Medical University of South Carolina
  • Prisma Health Richland Hospital
  • Greenville Health System Cancer Institute-Andrews
  • Saint Francis Hospital
  • BI-LO Charities Children's Cancer Center
  • Prisma Health Cancer Institute - Butternut
  • Prisma Health Cancer Institute - Faris
  • Prisma Health Greenville Memorial Hospital
  • Saint Francis Cancer Center
  • Prisma Health Cancer Institute - Eastside
  • Prisma Health Cancer Institute - Greer
  • Prisma Health Cancer Institute - Seneca
  • Sanford USD Medical Center - Sioux Falls
  • T C Thompson Children's Hospital
  • East Tennessee Childrens Hospital
  • Saint Jude Children's Research Hospital
  • The Children's Hospital at TriStar Centennial
  • Vanderbilt University/Ingram Cancer Center
  • Dell Children's Medical Center of Central Texas
  • Driscoll Children's Hospital
  • Medical City Dallas Hospital
  • Parkland Memorial Hospital
  • UT Southwestern/Simmons Cancer Center-Dallas
  • El Paso Children's Hospital
  • Cook Children's Medical Center
  • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
  • M D Anderson Cancer Center
  • Covenant Children's Hospital
  • UMC Cancer Center / UMC Health System
  • Texas Tech University Health Sciences Center-Lubbock
  • Children's Hospital of San Antonio
  • Methodist Children's Hospital of South Texas
  • University of Texas Health Science Center at San Antonio
  • Scott and White Memorial Hospital
  • Huntsman Cancer Institute/University of Utah
  • Primary Children's Hospital
  • South Jordan Health Center
  • Central Vermont Medical Center/National Life Cancer Treatment
  • University of Vermont Medical Center
  • University of Vermont and State Agricultural College
  • University of Virginia Cancer Center
  • Inova Fairfax Hospital
  • Children's Hospital of The King's Daughters
  • Virginia Commonwealth University/Massey Cancer Center
  • Carilion Children's
  • Providence Regional Cancer System-Aberdeen
  • PeaceHealth Saint Joseph Medical Center
  • Providence Regional Cancer System-Centralia
  • Providence Regional Cancer Partnership
  • Swedish Cancer Institute-Issaquah
  • Kadlec Clinic Hematology and Oncology
  • Providence Regional Cancer System-Lacey
  • PeaceHealth Saint John Medical Center
  • Seattle Children's Hospital
  • Swedish Medical Center-Ballard Campus
  • Kaiser Permanente Washington
  • Swedish Medical Center-First Hill
  • Providence Sacred Heart Medical Center and Children's Hospital
  • Madigan Army Medical Center
  • PeaceHealth Southwest Medical Center
  • Providence Saint Mary Regional Cancer Center
  • North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
  • West Virginia University Charleston Division
  • West Virginia University Healthcare
  • Aurora Cancer Care-Southern Lakes VLCC
  • Aurora Health Center-Fond du Lac
  • Aurora Health Care Germantown Health Center
  • Aurora Cancer Care-Grafton
  • Aurora BayCare Medical Center
  • Aurora Cancer Care-Kenosha South
  • University of Wisconsin Carbone Cancer Center
  • Aurora Bay Area Medical Group-Marinette
  • Marshfield Medical Center-Marshfield
  • Aurora Cancer Care-Milwaukee
  • Aurora Saint Luke's Medical Center
  • Children's Hospital of Wisconsin
  • Medical College of Wisconsin
  • Aurora Sinai Medical Center
  • Vince Lombardi Cancer Clinic - Oshkosh
  • Aurora Cancer Care-Racine
  • Vince Lombardi Cancer Clinic-Sheboygan
  • Aurora Medical Center in Summit
  • Vince Lombardi Cancer Clinic-Two Rivers
  • Aurora Cancer Care-Waukesha
  • Aurora Cancer Care-Milwaukee West
  • Aurora West Allis Medical Center
  • Cross Cancer Institute
  • British Columbia Children's Hospital
  • CancerCare Manitoba
  • Janeway Child Health Centre
  • IWK Health Centre
  • McMaster Children's Hospital at Hamilton Health Sciences
  • Children's Hospital
  • Hospital for Sick Children
  • CIUSSSEMTL-Hopital Maisonneuve-Rosemont
  • CHUM - Hopital Notre-Dame
  • CHUM - Centre Hospitalier de l'Universite de Montreal
  • The Montreal Children's Hospital of the MUHC
  • Centre Hospitalier Universitaire Sainte-Justine
  • Allan Blair Cancer Centre
  • CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
  • San Jorge Children's Hospital
  • University Pediatric Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Regimen A (pazopanib, chemoradiation)

Regimen B (chemoradiation)

Regimen C (pazopanib, radiation therapy)

Regimen D (radiation therapy)

Arm Description

See Regimen A Detailed Description.

See Regimen B Detailed Description.

INDUCTION PHASE: Patients receive pazopanib PO QD on weeks 1-9. Patients undergo radiation therapy on weeks 1-7. SURGERY: Patients undergo surgery on week 10. CONTINUATION PHASE: Patients receive pazopanib PO QD on weeks 13-25. If applicable, patients undergo additional radiation therapy at week 13.

INDUCTION PHASE: Patients undergo radiation therapy on weeks 1-7. SURGERY: Patients undergo surgery on week 10. CONTINUATION PHASE: If applicable, patients undergo additional radiation therapy at week 13.

Outcomes

Primary Outcome Measures

Feasible Dose: Pediatric
The dose of pazopanib that is feasible when given in combination with radiation or chemoradiation in pediatric unresected intermediate- and high-risk NRSTS patients. Initially, up to 10 patients (minimum of 3 patients ≥ 2 and < 18 years of age and 3 patients ≥ 18 years of age) eligible for each of the two study cohorts were non-randomly assigned (to generate 8 patients evaluable for toxicity) to receive treatment with pazopanib at dose level 1. A protocol-defined list of pazopanib-associated adverse events were defined as dose-limiting toxicities. The pazopanib dose determined to be feasible was based on the number of patient-reported dose-limiting toxicities encountered.
Feasible Dose: Adult
The dose of pazopanib that is feasible when given in combination with radiation or chemoradiation in adult unresected intermediate- and high-risk NRSTS patients. Initially, up to 10 patients (minimum of 3 patients ≥ 2 and < 18 years of age and 3 patients ≥ 18 years of age) eligible for each of the two study cohorts were non-randomly assigned (to generate 8 patients evaluable for toxicity) to receive treatment with pazopanib at dose level 1. A protocol-defined list of pazopanib-associated adverse events were defined as dose-limiting toxicities. The pazopanib dose determined to be feasible was based on the number of patient-reported dose-limiting toxicities encountered.
Percentage of Chemoradiotherapy Patients With Positive Pathologic Response at Week 13
A responder is defined by more than (90% tumor necrosis at week 13). A non-responder has less than 90% necrosis or progressive disease before week 13.
Percentage of Radiotherapy Patients With Positive Pathologic Response at Week 10
A responder is defined by more than 90% tumor necrosis at week 10. A non-responder has less than 90% necrosis or progressive disease before week 10.
Percentage of Radiotherapy Patients Failure Free at 5 Years Following Study Entry
Time to the first occurrence of relapse, progression, secondary cancer or death from any cause.

Secondary Outcome Measures

Percentage of Patients Local Failure Free at 5 Years Following Study Entry
Defined as disease recurrence only at the primary site of disease at diagnosis. The relative risk of specific failure types will be estimated and compared descriptively using the Cox proportional hazard model.
Percentage of Patients Regional Failure Free at 5 Years Following Study Entry
Defined as disease recurrence at lymph nodes regional to the primary disease site, with or without local failure but without distant failure. The relative risk of specific failure types will be estimated and compared descriptively using the Cox proportional hazard model.
Percentage of Patients Distant Failure Free at 5 Years Following Study Entry
Defined as disease recurrence at sites other than the primary site and diagnosis and nodes regional to that site (metastatic disease, whether or not present at diagnosis), with or without loco-regional failure. The relative risk of specific failure types will be estimated and compared descriptively using the Cox proportional hazard model.
Percentage of Patients Who Experienced Grade 3 or Higher Toxicity Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
Participants who experienced Grade 3 or higher toxicity was assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).

Full Information

First Posted
July 1, 2014
Last Updated
October 24, 2023
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT02180867
Brief Title
Radiation Therapy With or Without Combination Chemotherapy or Pazopanib Before Surgery in Treating Patients With Newly Diagnosed Non-rhabdomyosarcoma Soft Tissue Sarcomas That Can Be Removed by Surgery
Official Title
Pazopanib Neoadjuvant Trial in Non-Rhabdomyosarcoma Soft Tissue Sarcomas (PAZNTIS): A Phase II/III Randomized Trial of Preoperative Chemoradiation or Preoperative Radiation Plus or Minus Pazopanib (NSC# 737754)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 11, 2014 (Actual)
Primary Completion Date
June 30, 2019 (Actual)
Study Completion Date
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3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This randomized phase II/III trial studies how well pazopanib, when combined with chemotherapy and radiation therapy or radiation therapy alone, work in the treatment of patients with newly diagnosed non-rhabdomyosarcoma soft tissue sarcomas that can eventually be removed by surgery. Radiation therapy uses high energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as ifosfamide and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Pazopanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether these therapies can be safely combined and if they work better when given together in treating patients with non-rhabdomyosarcoma soft tissue sarcomas.
Detailed Description
PRIMARY OBJECTIVES: I. To identify the dose of pazopanib that is feasible when given in combination with radiation or chemoradiation in pediatric and adult patients newly diagnosed with unresected intermediate- and high-risk non rhabdomyosarcoma soft tissue sarcomas (NRSTS). II. To compare the rates of near complete pathologic response (> 90% necrosis) with the addition of pazopanib to preoperative chemoradiation versus preoperative chemoradiation alone for potentially resectable > 5 cm, grade 2 or 3 intermediate to high risk chemotherapy-sensitive NRSTS in the phase II portion of the study for this cohort. III. To compare the rates of near complete pathologic response (> 90% necrosis) with the addition of pazopanib to preoperative radiotherapy versus preoperative radiotherapy alone for potentially resectable intermediate to high risk adult and pediatric NRSTS in the phase II portion of the study for this cohort (using a phase II decision rule to go onto the phase III portion of the study). IV. To compare the rates of event-free survival (EFS) with the addition of pazopanib to preoperative radiotherapy versus preoperative radiotherapy alone for localized intermediate to high risk adult and pediatric NRSTS in the phase III portion of the study for this cohort if the phase II decision rule is passed. SECONDARY OBJECTIVES: I. To estimate the rates of local failure, regional failure, distant metastasis free survival, disease-free survival, and overall survival with the addition of pazopanib to preoperative chemoradiation or preoperative radiation in intermediate to high risk adult and pediatric NRSTS. II. To compare the pattern of recurrence (local, regional and distant) between preoperative chemoradiation or radiation with the addition of pazopanib for adult and pediatric NRSTS. III. To define the toxicities of ifosfamide and doxorubicin chemotherapy and radiation when used in combination with pazopanib in intermediate to high risk adult and pediatric NRSTS. IV. To define the toxicities of preoperative radiotherapy when used in combination with pazopanib in intermediate to high risk adult and pediatric NRSTS. EXPLORATORY OBJECTIVES: I. To gain insight into the disease biology of childhood and adult NRSTS through analysis of actionable mutations and whole genome sequencing. II. To determine if microvessel density and circulating tumor deoxyribonucleic acid (DNA) predict response to pazopanib and outcome. III. To determine the effect of pazopanib on doxorubicin exposure in children and adults with NRSTS. IV. To evaluate change in fludeoxyglucose F 18 (FDG) positron emission tomography (PET) maximum standard uptake value (SUVmax) from baseline to week 10 or 13 in patients with unresected tumors and to correlate this change with pathologic response and EFS. V. To compare the rate of response by standard imaging and pathologic assessment to determine which correlates better with local tumor control, distant tumor control, EFS, and overall survival. OUTLINE: This study starts as a dose-escalation study of pazopanib. CHEMOTHERAPY COHORT: Patients eligible for chemotherapy cohort are randomized to 1 of 2 treatment regimens. REGIMEN A: INDUCTION PHASE: Patients receive pazopanib orally (PO) once daily (QD) on weeks 1-12, ifosfamide intravenously (IV) over 2-4 hours on days 1-3 on weeks 1, 4, 7, 10, and doxorubicin IV over 1-15 minutes on days 1-2 on weeks 1 and 4. At least 24 hours after the completion of week 4 doxorubicin, patients undergo radiation therapy on weeks 4-10. SURGERY: Patients undergo surgery on week 13. CONTINUATION PHASE: Patients receive pazopanib PO QD on weeks 16-25, ifosfamide IV over 2-4 hours on days 1-3 on weeks 16 and 19, and doxorubicin IV over 1-15 minutes on days 1-2 on weeks 16, 19, and 22. If applicable, patients undergo additional radiation therapy at week 16 REGIMEN B: INDUCTION PHASE: Patients receive ifosfamide IV over 2-4 hours on days 1-3 on weeks 1, 4, 7, 10 and doxorubicin hydrochloride IV over 1-15 minutes on days 1-2 on weeks 1 and 4. At least 24 hours after the completion of week 4 doxorubicin, patients undergo radiation therapy on weeks 4-10. SURGERY: Patients undergo surgery on week 13. CONTINUATION PHASE: Patients receive ifosfamide IV over 2-4 hours on days 1-3 on weeks 16 and 19 and doxorubicin IV over 1-15 minutes on days 1-2 on weeks 16, 19, and 22. If applicable, patients undergo additional radiation therapy at week 16. NON-CHEMOTHERAPY COHORT: Patients eligible for non-chemotherapy cohort are randomized to 1 of 2 treatment regimens. REGIMEN C: INDUCTION PHASE: Patients receive pazopanib PO QD on weeks 1-9. Patients undergo radiation therapy on weeks 1-7. SURGERY: Patients undergo surgery on week 10. CONTINUATION PHASE: Patients receive pazopanib PO QD on weeks 13-25. If applicable, patients undergo additional radiation therapy at week 13. REGIMEN D: INDUCTION PHASE: Patients undergo radiation therapy on weeks 1-7. SURGERY: Patients undergo surgery on week 10. CONTINUATION PHASE: If applicable, patients undergo additional radiation therapy at week 13. After completion of study treatment, patients are followed up at 6, 12, 18, 24, 30, 36, 48, and 60 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Soft Part Sarcoma, Angiomatoid Fibrous Histiocytoma, Atypical Fibroxanthoma, Clear Cell Sarcoma of Soft Tissue, Epithelioid Malignant Peripheral Nerve Sheath Tumor, Epithelioid Sarcoma, Extraskeletal Myxoid Chondrosarcoma, Extraskeletal Osteosarcoma, Fibrohistiocytic Neoplasm, Fibrosarcoma, Inflammatory Myofibroblastic Tumor, Intimal Sarcoma, Leiomyosarcoma, Liposarcoma, Liver Embryonal Sarcoma, Low Grade Fibromyxoid Sarcoma, Low Grade Myofibroblastic Sarcoma, Malignant Cutaneous Granular Cell Tumor, Malignant Peripheral Nerve Sheath Tumor, Malignant Triton Tumor, Mesenchymal Chondrosarcoma, Myxofibrosarcoma, Myxoid Chondrosarcoma, Myxoinflammatory Fibroblastic Sarcoma, Nerve Sheath Neoplasm, PEComa, Pericytic Neoplasm, Plexiform Fibrohistiocytic Tumor, Sclerosing Epithelioid Fibrosarcoma, Skin Glomus Tumor, Stage IB Soft Tissue Sarcoma AJCC v7, Stage IIB Soft Tissue Sarcoma AJCC v7, Stage III Soft Tissue Sarcoma AJCC v7, Stage IV Soft Tissue Sarcoma AJCC v7, Synovial Sarcoma, Undifferentiated High Grade Pleomorphic Sarcoma of Bone

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
140 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Regimen A (pazopanib, chemoradiation)
Arm Type
Experimental
Arm Description
See Regimen A Detailed Description.
Arm Title
Regimen B (chemoradiation)
Arm Type
Experimental
Arm Description
See Regimen B Detailed Description.
Arm Title
Regimen C (pazopanib, radiation therapy)
Arm Type
Experimental
Arm Description
INDUCTION PHASE: Patients receive pazopanib PO QD on weeks 1-9. Patients undergo radiation therapy on weeks 1-7. SURGERY: Patients undergo surgery on week 10. CONTINUATION PHASE: Patients receive pazopanib PO QD on weeks 13-25. If applicable, patients undergo additional radiation therapy at week 13.
Arm Title
Regimen D (radiation therapy)
Arm Type
Experimental
Arm Description
INDUCTION PHASE: Patients undergo radiation therapy on weeks 1-7. SURGERY: Patients undergo surgery on week 10. CONTINUATION PHASE: If applicable, patients undergo additional radiation therapy at week 13.
Intervention Type
Drug
Intervention Name(s)
Doxorubicin
Other Intervention Name(s)
Adriablastin, Hydroxydaunomycin, Hydroxyl Daunorubicin, Hydroxyldaunorubicin
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Doxorubicin Hydrochloride
Other Intervention Name(s)
5,12-Naphthacenedione, 10-[(3-amino-2,3,6-trideoxy-alpha-L-lyxo-hexopyranosyl)oxy]-7,8, 9,10-tetrahydro-6,8,11-trihydroxy-8-(hydroxyacetyl)-1-methoxy-, hydrochloride, (8S-cis)- (9CI), ADM, Adriacin, Adriamycin, Adriamycin Hydrochloride, Adriamycin PFS, Adriamycin RDF, ADRIAMYCIN, HYDROCHLORIDE, Adriamycine, Adriblastina, Adriblastine, Adrimedac, Chloridrato de Doxorrubicina, DOX, DOXO-CELL, Doxolem, Doxorubicin HCl, Doxorubicin.HCl, Doxorubin, Farmiblastina, FI 106, FI-106, hydroxydaunorubicin, Rubex
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Ifosfamide
Other Intervention Name(s)
Asta Z 4942, Asta Z-4942, Cyfos, Holoxan, Holoxane, Ifex, IFO, IFO-Cell, Ifolem, Ifomida, Ifomide, Ifosfamidum, Ifoxan, IFX, Iphosphamid, Iphosphamide, Iso-Endoxan, Isoendoxan, Isophosphamide, Mitoxana, MJF 9325, MJF-9325, Naxamide, Seromida, Tronoxal, Z 4942, Z-4942
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
Pazopanib
Other Intervention Name(s)
GW786034
Intervention Description
Given PO
Intervention Type
Drug
Intervention Name(s)
Pazopanib Hydrochloride
Other Intervention Name(s)
GW786034B, Pazopater, Votrient
Intervention Description
Given PO
Intervention Type
Radiation
Intervention Name(s)
Radiation Therapy
Other Intervention Name(s)
Cancer Radiotherapy, Energy Type, ENERGY_TYPE, Irradiate, Irradiated, Irradiation, Radiation, Radiation Therapy, NOS, Radiotherapeutics, Radiotherapy, RT, Therapy, Radiation
Intervention Description
Undergo radiation therapy
Intervention Type
Procedure
Intervention Name(s)
Therapeutic Conventional Surgery
Intervention Description
Undergo surgery
Primary Outcome Measure Information:
Title
Feasible Dose: Pediatric
Description
The dose of pazopanib that is feasible when given in combination with radiation or chemoradiation in pediatric unresected intermediate- and high-risk NRSTS patients. Initially, up to 10 patients (minimum of 3 patients ≥ 2 and < 18 years of age and 3 patients ≥ 18 years of age) eligible for each of the two study cohorts were non-randomly assigned (to generate 8 patients evaluable for toxicity) to receive treatment with pazopanib at dose level 1. A protocol-defined list of pazopanib-associated adverse events were defined as dose-limiting toxicities. The pazopanib dose determined to be feasible was based on the number of patient-reported dose-limiting toxicities encountered.
Time Frame
After the first 6 weeks of Induction
Title
Feasible Dose: Adult
Description
The dose of pazopanib that is feasible when given in combination with radiation or chemoradiation in adult unresected intermediate- and high-risk NRSTS patients. Initially, up to 10 patients (minimum of 3 patients ≥ 2 and < 18 years of age and 3 patients ≥ 18 years of age) eligible for each of the two study cohorts were non-randomly assigned (to generate 8 patients evaluable for toxicity) to receive treatment with pazopanib at dose level 1. A protocol-defined list of pazopanib-associated adverse events were defined as dose-limiting toxicities. The pazopanib dose determined to be feasible was based on the number of patient-reported dose-limiting toxicities encountered.
Time Frame
After the first 6 weeks of Induction
Title
Percentage of Chemoradiotherapy Patients With Positive Pathologic Response at Week 13
Description
A responder is defined by more than (90% tumor necrosis at week 13). A non-responder has less than 90% necrosis or progressive disease before week 13.
Time Frame
Week 13 after induction
Title
Percentage of Radiotherapy Patients With Positive Pathologic Response at Week 10
Description
A responder is defined by more than 90% tumor necrosis at week 10. A non-responder has less than 90% necrosis or progressive disease before week 10.
Time Frame
Week 10 after induction
Title
Percentage of Radiotherapy Patients Failure Free at 5 Years Following Study Entry
Description
Time to the first occurrence of relapse, progression, secondary cancer or death from any cause.
Time Frame
From enrollment to up to 60 months
Secondary Outcome Measure Information:
Title
Percentage of Patients Local Failure Free at 5 Years Following Study Entry
Description
Defined as disease recurrence only at the primary site of disease at diagnosis. The relative risk of specific failure types will be estimated and compared descriptively using the Cox proportional hazard model.
Time Frame
From enrollment to up to 60 months
Title
Percentage of Patients Regional Failure Free at 5 Years Following Study Entry
Description
Defined as disease recurrence at lymph nodes regional to the primary disease site, with or without local failure but without distant failure. The relative risk of specific failure types will be estimated and compared descriptively using the Cox proportional hazard model.
Time Frame
From enrollment to up to 60 months
Title
Percentage of Patients Distant Failure Free at 5 Years Following Study Entry
Description
Defined as disease recurrence at sites other than the primary site and diagnosis and nodes regional to that site (metastatic disease, whether or not present at diagnosis), with or without loco-regional failure. The relative risk of specific failure types will be estimated and compared descriptively using the Cox proportional hazard model.
Time Frame
From enrollment to up to 60 months
Title
Percentage of Patients Who Experienced Grade 3 or Higher Toxicity Assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE)
Description
Participants who experienced Grade 3 or higher toxicity was assessed by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE).
Time Frame
Reporting of adverse events was required from the start of protocol therapy and until 30 days from the last administration of study drugs; up to 1 year
Other Pre-specified Outcome Measures:
Title
Relative Frequency of Actionable Mutations
Description
Descriptive statistical analyses will be provided to estimate the relative frequency of actionable mutations across the whole cohort and within more common histological subtypes, like synovial sarcoma and malignant peripheral nerve sheath tumors.
Time Frame
At diagnosis
Title
Prevalence of Circulating Tumor DNA (ctDNA)
Description
Descriptive analyses will be performed to summarize the prevalence of ctDNA.
Time Frame
At diagnosis
Title
Mean Pharmacokinetic Parameters of Doxorubicin and Pazopanib
Description
Pharmacokinetic parameters such as the clearance of doxorubicin and pazopanib will be estimated.
Time Frame
Up to 48 hours after the end of infusion
Title
Change in Fludeoxyglucose F 18 (FDG) Positron Emission Tomography (PET) Maximum Standard Uptake Value (SUVmax)
Description
To evaluate change in FDG PET maximum standard uptake value (SUVmax) from baseline to Week 10 or 13 in patients with unresected tumors and to correlate this change with pathologic response and EFS.
Time Frame
From enrollment to week 10 or 13 prior to tumor resection
Title
Relative Risk of Failure Based on Both Standard Imaging and Pathologic Assessment
Description
To compare the rate of response by standard imaging and pathologic assessment to determine which correlates better with local tumor control, distant tumor control, event free survival, and overall survival.
Time Frame
From enrollment up to 60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Note: eligible patients must have a body surface area >= 0.5 m^2 AND be able to swallow whole tablets Newly diagnosed and histopathologically confirmed, potentially resectable NRSTS of the extremity and trunk will be eligible for the chemotherapy or non-chemotherapy cohort based on: Evidence of chemotherapy sensitivity of the histologic sarcoma subtype based on existing evidence from prior clinical trials Sufficient risk of metastatic disease to warrant chemotherapy based on size and grade and Medically deemed able or unable to undergo chemotherapy Notes: an incisional biopsy or core biopsy is preferred; fine needle aspiration biopsy is not acceptable to establish the diagnosis ELIGIBLE SITES: Extremities: upper (including shoulder) and lower (including hip) Trunk: body wall INELIGIBLE SITES: Head and neck, visceral organs (with the exception of embryonal sarcoma of the liver), retroperitoneum, peritoneum, pelvis within the confines of the bony pelvis ELIGIBILITY FOR CHEMOTHERAPY COHORT: Stage T2a/b (> 5 cm) and grade 2 or 3 AND One of the following chemosensitive histologies as defined in the World Health Organization (WHO) classification of soft tissue tumors (with some evidence of good response to chemoradiation and of sufficient high risk of metastases, or clear evidence of metastases): Unclassified soft tissue sarcomas that are too undifferentiated to be placed in a specific pathologic category in the WHO classification (often called "undifferentiated soft tissue sarcoma" or "soft tissue sarcoma not otherwise specified [NOS]") Synovial sarcoma Angiosarcoma of soft tissue Adult fibrosarcoma Mesenchymal (extraskeletal) chondrosarcoma Leiomyosarcoma Liposarcoma (excluding myxoid liposarcoma) Undifferentiated pleomorphic sarcoma Embryonal sarcoma of the liver Patients meeting the above criteria (histology, size, and grade) with the EXCEPTION of histologies noted above may enroll on the chemotherapy cohort or the non-chemotherapy cohort at the discretion of the enrolling investigator; patients meeting these criteria with the EXCEPTION of histologies noted above but medically deemed unable to receive chemotherapy or who elect not to receive chemotherapy are eligible for the non-chemotherapy cohort Patients with the following histologies are only eligible for the chemotherapy cohort and cannot enroll on the non-chemotherapy cohort: Unclassified soft tissue sarcomas that are too undifferentiated to be placed in a specific pathologic category in the WHO classification (often called "undifferentiated soft tissue sarcoma" or "soft tissue sarcoma NOS") in patients < 30 years of age Synovial sarcoma Embryonal sarcoma of the liver ELIGIBILITY FOR NON-CHEMOTHERAPY COHORT: Patients with any size of grade 2 or 3 of the following "intermediate (rarely metastasizing)" or "malignant" tumors, as defined in the WHO classification of soft tissue tumors for which we have consensus data of chemotherapy-resistance are eligible only for the non-chemotherapy cohort: So-called fibrohistiocytic tumors - plexiform fibrohistiocytic tumor, giant cell tumor of soft tissues Fibroblastic/myofibroblastic tumors - solitary fibrous tumor, malignant solitary fibrous tumor, inflammatory myofibroblastic tumor, low grade myofibroblastic sarcoma, myxoinflammatory fibroblastic sarcoma, atypical myxoinflammatory fibroblastic tumor, myxofibrosarcoma, low grade fibromyxoid sarcoma, sclerosing epithelioid fibrosarcoma Tumors of uncertain differentiation - epithelioid sarcoma, alveolar soft part sarcoma, clear cell sarcoma of soft tissue, angiomatoid fibrous histiocytoma, ossifying fibromyxoid tumor, myoepithelioma, myoepithelial carcinoma, extraskeletal myxoid chondrosarcoma, neoplasms with perivascular epithelioid cell differentiation (PEComa), intimal sarcoma, atypical fibroxanthoma, mixed tumor NOS, phosphaturic mesenchymal tumor, malignant ossifying fibromyxoid tumor, malignant mixed tumor, malignant phosphaturic mesenchymal tumor Chondro-osseous tumors - extraskeletal osteosarcoma Pericytic (perivascular) tumors - malignant glomus tumor Nerve sheath tumors - malignant peripheral nerve sheath tumor, malignant granular cell tumor, epithelioid malignant peripheral nerve sheath tumor, malignant Triton tumor Undifferentiated sarcomas (with a specific pathologic category in the WHO classification) - undifferentiated round cell sarcoma, undifferentiated epithelioid sarcoma, undifferentiated spindle cell sarcoma Patients meeting the criteria (histology, size, and grade) with the EXCEPTION of histologies noted above may enroll on the non-chemotherapy cohort at the discretion of the enrolling investigator; patients meeting these criteria with the EXCEPTION of histologies noted above but medically deemed unable to receive chemotherapy or who elect not to receive chemotherapy are eligible for the non-chemotherapy cohort; note that tumors arising in bone are NOT eligible for this study Extent of disease: Patients with non-metastatic and metastatic disease are eligible Initially unresectable patients, with or without metastatic disease, are eligible as long as there is a commitment at enrollment to resect the primary tumor Sufficient tissue and blood must be available to submit for required biology studies Lansky performance status score >= 70 for patients =< 16 years of age Karnofsky performance status score >= 70 for patients > 16 years of age Absolute neutrophil count >= 1500/uL; Note: no transfusions are permitted 7 days prior to laboratory studies to determine eligibility Platelet count >= 100,000/uL; Note: no transfusions are permitted 7 days prior to laboratory studies to determine eligibility Hemoglobin >= 8 g/dL for patients =< 16 years of age; >= 9 g/dL for patients > 16 years of age; Note: no transfusions are permitted 7 days prior to laboratory studies to determine eligibility Creatinine clearance or radioisotope glomerular filtration rate (GFR) >= 70 mL/min/1.73 m^2 or normal serum creatinine based on age/gender as follows: 2 to < 6 years; 0.8 mg/dL male; 0.8 mg/dL female 6 to < 10 years; 1 mg/dL male; 1 mg/dL female 10 to < 13 years; 1.2 mg/dL male; 1.2 mg/dL female 13 to < 16 years; 1.5 mg/dL male; 1.4 mg/dL female >= 16 years; 1.5 mg/dL male; 1.4 mg/dL female Total bilirubin =< 1.5 x upper limit of normal (ULN) for age Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x upper limit of normal (ULN) for age Shortening fraction of >= 27% by echocardiogram OR ejection fraction of >= 50% by radionuclide angiogram Corrected QT interval (QTc) < 480 msec No evidence of dyspnea at rest, no exercise intolerance, and a resting pulse oximetry reading > 94% on room air if there is clinical indication for determination Patients on low molecular weight heparin or Coumadin (with a stable international normalized ratio [INR]) are eligible Patient must have a life expectancy of at least 3 months with appropriate therapy All patients and/or their parents or legal guardians must sign a written informed consent All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met Exclusion Criteria: Patients with grade 1 NRSTS tumors of any size are not eligible Patients with known central nervous system (CNS) metastases are not eligible; Note: brain imaging is not an eligibility requirement Patients with evidence of active bleeding or bleeding diathesis will be excluded (Note: patients aged > 17 years with excess of 2.5 mL of hemoptysis are not eligible) Patients with gross total resection of the primary tumor prior to enrollment on ARST1321 are NOT eligible; patients who have experienced tumor recurrence after a gross total tumor resection are NOT eligible Patients with uncontrolled hypertension are ineligible; uncontrolled hypertension is defined as follows: Patients aged =< 17 years: greater than 95th percentile systolic and diastolic blood pressure based on age and height which is not controlled by one anti-hypertensive medication Patients aged > 17 years: systolic blood pressure >= 140 mmHg and/or diastolic blood pressure >= 90 mmHg that is not controlled by one anti-hypertensive medication Prior Therapy: Patients must have had no prior anthracycline (e.g., doxorubicin, daunorubicin) or ifosfamide chemotherapy Patients must have had no prior use of pazopanib or similar multi-targeted tyrosine kinase inhibitors (TKI) Patients must have had no prior radiotherapy to tumor-involved sites Note: patients previously treated for a non-NRSTS cancer are eligible provided they meet the prior therapy requirements; patients who have had chemotherapy or radiotherapy within 4 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier are excluded Other types of invasive malignancy that are not disease free within 3 years except for non-melanoma skin cancer, lentigo maligna, any carcinoma-in-situ or prostate cancer with low risk factors CYTOCHROME P450 3A4 (CYP3A4) substrates WITH narrow therapeutic indices: patients chronically receiving medications known to be metabolized by CYP3A4 and with narrow therapeutic indices within 7 days prior to study enrollment, including but not limited to pimozide, aripiprazole, triazolam, ergotamine and halofantrine are not eligible; Note: the use of fentanyl is permitted CYP3A4 Inhibitors: patients chronically receiving drugs that are known potent CYP3A4 inhibitors within 7 days prior to study enrollment, including but not limited to itraconazole, clarithromycin, erythromycin many non-nucleoside reverse-transcriptase inhibitors (NNRTIs), diltiazem, verapamil, and grapefruit juice are not eligible CYP3A4 Inducers: patients chronically receiving drugs that are known potent CYP3A4 inducers within 14 days prior to study enrollment, including but not limited to carbamazepine, phenobarbital, phenytoin, rifampin, and St. John's wort are not eligible (with the exception of glucocorticoids) Certain medications that are associated with a risk for QTc prolongation and/or Torsades de Pointes, although not prohibited, should be avoided or replaced with medications that do not carry these risks, if possible Subjects with any condition that may impair the ability to swallow or absorb oral medications/investigational product including: Any lesion, whether induced by tumor, radiation or other conditions, which makes it difficult to swallow capsules or pills Prior surgical procedures affecting absorption including, but not limited to major resection of stomach or small bowel Active peptic ulcer disease Malabsorption syndrome Subjects with any condition that may increase the risk of gastrointestinal bleeding or gastrointestinal perforation, including: Active peptic ulcer disease Known intraluminal metastatic lesions Inflammatory bowel disease (e.g., ulcerative colitis, Crohn's disease) or other gastrointestinal conditions which increase the risk of perforation History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 28 days prior to beginning study treatment Subjects with any of the following cardiovascular conditions within the past 6 months Cerebrovascular accident (CVA) or transient ischemic attack (TIA) Cardiac arrhythmia Admission for unstable angina Cardiac angioplasty or stenting Coronary artery bypass graft surgery Pulmonary embolism, untreated deep venous thrombosis (DVT) or DVT which has been treated with therapeutic anticoagulation for less than 6 weeks Arterial thrombosis Symptomatic peripheral vascular disease Class III or IV heart failure as defined by the New York Heart Association (NYHA) functional classification system; a subject who has a history of class II heart failure and is asymptomatic on treatment may be considered eligible History of serious or non-healing wound, ulcer, or bone fracture Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements Patients who are unable to swallow whole tablets are not eligible Patients with a body surface area < 0.5 m^2 are not eligible Human immunodeficiency virus (HIV)-positive subjects on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with pazopanib; in addition, these subjects are at increased risk of lethal infections when treated with marrow-suppressive therapy Patients who are receiving any other investigational agent(s) Pregnancy and breast feeding: Female patients who are pregnant are ineligible due to risks of fetal and teratogenic adverse events as seen in animal/human studies Lactating females are not eligible unless they have agreed not to breastfeed their infants during treatment and for a period of 1 month following completion of treatment Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained Unwillingness to use an effective contraceptive method for the duration of their study participation and for at least 1 month after treatment is completed if sexually active with reproductive potential
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aaron R Weiss
Organizational Affiliation
Children's Oncology Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Alabama
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
University of Alabama at Birmingham Cancer Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
The Kirklin Clinic at Acton Road
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35243
Country
United States
Facility Name
Anchorage Associates in Radiation Medicine
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
98508
Country
United States
Facility Name
Alaska Breast Care and Surgery LLC
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Alaska Oncology and Hematology LLC
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Alaska Women's Cancer Care
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Anchorage Oncology Centre
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Katmai Oncology Group
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Providence Alaska Medical Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Banner Children's at Desert
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85202
Country
United States
Facility Name
Phoenix Childrens Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Facility Name
Banner University Medical Center - Tucson
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202-3591
Country
United States
Facility Name
Kaiser Permanente-Anaheim
City
Anaheim
State/Province
California
ZIP/Postal Code
92806
Country
United States
Facility Name
AIS Cancer Center at San Joaquin Community Hospital
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
Facility Name
Providence Saint Joseph Medical Center/Disney Family Cancer Center
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Kaiser Permanente Downey Medical Center
City
Downey
State/Province
California
ZIP/Postal Code
90242
Country
United States
Facility Name
City of Hope Comprehensive Cancer Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Miller Children's and Women's Hospital Long Beach
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Children's Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Kaiser Permanente Los Angeles Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Los Angeles County-USC Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
USC / Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
UCLA / Jonsson Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Valley Children's Hospital
City
Madera
State/Province
California
ZIP/Postal Code
93636
Country
United States
Facility Name
UCSF Benioff Children's Hospital Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Kaiser Permanente-Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94611
Country
United States
Facility Name
Children's Hospital of Orange County
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Lucile Packard Children's Hospital Stanford University
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Stanford Cancer Institute Palo Alto
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Kaiser Permanente-Riverside
City
Riverside
State/Province
California
ZIP/Postal Code
92505
Country
United States
Facility Name
Sutter Medical Center Sacramento
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
University of California Davis Comprehensive Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Kaiser Permanente-San Diego Zion
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Rady Children's Hospital - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
UCSF Medical Center-Mission Bay
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Facility Name
Kaiser Permanente-San Marcos
City
San Marcos
State/Province
California
ZIP/Postal Code
92078
Country
United States
Facility Name
Kaiser San Rafael-Gallinas
City
San Rafael
State/Province
California
ZIP/Postal Code
94903
Country
United States
Facility Name
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Gene Upshaw Memorial Tahoe Forest Cancer Center
City
Truckee
State/Province
California
ZIP/Postal Code
96161
Country
United States
Facility Name
Children's Hospital Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
UCHealth University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
UCHealth Memorial Hospital Central
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Poudre Valley Hospital
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80524
Country
United States
Facility Name
Connecticut Children's Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06106
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Facility Name
Alfred I duPont Hospital for Children
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19803
Country
United States
Facility Name
MedStar Georgetown University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Children's National Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
UM Sylvester Comprehensive Cancer Center at Deerfield Beach
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33442
Country
United States
Facility Name
Golisano Children's Hospital of Southwest Florida
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33908
Country
United States
Facility Name
University of Florida Health Science Center - Gainesville
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Nemours Children's Clinic-Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
University of Miami Miller School of Medicine-Sylvester Cancer Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Nicklaus Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
AdventHealth Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Nemours Children's Hospital
City
Orlando
State/Province
Florida
ZIP/Postal Code
32827
Country
United States
Facility Name
Nemours Children's Clinic - Pensacola
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32504
Country
United States
Facility Name
Johns Hopkins All Children's Hospital
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Facility Name
Saint Joseph's Hospital/Children's Hospital-Tampa
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Saint Mary's Hospital
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Emory University Hospital Midtown
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
Facility Name
Children's Healthcare of Atlanta - Egleston
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Emory University Hospital/Winship Cancer Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Augusta University Medical Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Memorial Health University Medical Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31404
Country
United States
Facility Name
Straub Clinic and Hospital
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Kaiser Permanente Moanalua Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96819
Country
United States
Facility Name
Kapiolani Medical Center for Women and Children
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96826
Country
United States
Facility Name
Saint Luke's Cancer Institute - Boise
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Saint Luke's Cancer Institute - Fruitland
City
Fruitland
State/Province
Idaho
ZIP/Postal Code
83619
Country
United States
Facility Name
Saint Luke's Cancer Institute - Meridian
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Saint Luke's Cancer Institute - Nampa
City
Nampa
State/Province
Idaho
ZIP/Postal Code
83686
Country
United States
Facility Name
Saint Luke's Cancer Institute - Twin Falls
City
Twin Falls
State/Province
Idaho
ZIP/Postal Code
83301
Country
United States
Facility Name
Lurie Children's Hospital-Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago Comprehensive Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Northwestern Medicine Cancer Center Delnor
City
Geneva
State/Province
Illinois
ZIP/Postal Code
60134
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Good Samaritan Regional Health Center
City
Mount Vernon
State/Province
Illinois
ZIP/Postal Code
62864
Country
United States
Facility Name
UC Comprehensive Cancer Center at Silver Cross
City
New Lenox
State/Province
Illinois
ZIP/Postal Code
60451
Country
United States
Facility Name
Advocate Children's Hospital-Oak Lawn
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Advocate Children's Hospital-Park Ridge
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068
Country
United States
Facility Name
Saint Jude Midwest Affiliate
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Saint John's Hospital
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Southern Illinois University School of Medicine
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62702
Country
United States
Facility Name
Memorial Medical Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62781
Country
United States
Facility Name
Northwestern Medicine Cancer Center Warrenville
City
Warrenville
State/Province
Illinois
ZIP/Postal Code
60555
Country
United States
Facility Name
Riley Hospital for Children
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Ascension Saint Vincent Indianapolis Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Reid Health
City
Richmond
State/Province
Indiana
ZIP/Postal Code
47374
Country
United States
Facility Name
Blank Children's Hospital
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Iowa Methodist Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Medical Oncology and Hematology Associates-Des Moines
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50309
Country
United States
Facility Name
Broadlawns Medical Center
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50314
Country
United States
Facility Name
Iowa Lutheran Hospital
City
Des Moines
State/Province
Iowa
ZIP/Postal Code
50316
Country
United States
Facility Name
University of Iowa/Holden Comprehensive Cancer Center
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Siouxland Regional Cancer Center
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
Country
United States
Facility Name
Methodist West Hospital
City
West Des Moines
State/Province
Iowa
ZIP/Postal Code
50266-7700
Country
United States
Facility Name
Newman Regional Health
City
Emporia
State/Province
Kansas
ZIP/Postal Code
66801
Country
United States
Facility Name
Central Care Cancer Center - Garden City
City
Garden City
State/Province
Kansas
ZIP/Postal Code
67846
Country
United States
Facility Name
Saint Catherine Hospital
City
Garden City
State/Province
Kansas
ZIP/Postal Code
67846
Country
United States
Facility Name
Central Care Cancer Center - Great Bend
City
Great Bend
State/Province
Kansas
ZIP/Postal Code
67530
Country
United States
Facility Name
Saint Rose Ambulatory and Surgery Center
City
Great Bend
State/Province
Kansas
ZIP/Postal Code
67530
Country
United States
Facility Name
HaysMed University of Kansas Health System
City
Hays
State/Province
Kansas
ZIP/Postal Code
67601
Country
United States
Facility Name
University of Kansas Cancer Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Olathe Health Cancer Center
City
Olathe
State/Province
Kansas
ZIP/Postal Code
66061
Country
United States
Facility Name
University of Kansas Cancer Center-Overland Park
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66210
Country
United States
Facility Name
Ascension Via Christi - Pittsburg
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Facility Name
Salina Regional Health Center
City
Salina
State/Province
Kansas
ZIP/Postal Code
67401
Country
United States
Facility Name
University of Kansas Health System Saint Francis Campus
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
University of Kansas Hospital-Westwood Cancer Center
City
Westwood
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
University of Kentucky/Markey Cancer Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Norton Children's Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Norton Hospital Pavilion and Medical Campus
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Norton Suburban Hospital and Medical Campus
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40207
Country
United States
Facility Name
Children's Hospital New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70118
Country
United States
Facility Name
Ochsner Medical Center Jefferson
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70121
Country
United States
Facility Name
Eastern Maine Medical Center
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
Maine Children's Cancer Program
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Sinai Hospital of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Johns Hopkins University/Sidney Kimmel Cancer Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Walter Reed National Military Medical Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20889-5600
Country
United States
Facility Name
Massachusetts General Hospital Cancer Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
UMass Memorial Medical Center - University Campus
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States
Facility Name
C S Mott Children's Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Bronson Battle Creek
City
Battle Creek
State/Province
Michigan
ZIP/Postal Code
49017
Country
United States
Facility Name
Henry Ford Cancer Institute-Downriver
City
Brownstown
State/Province
Michigan
ZIP/Postal Code
48183
Country
United States
Facility Name
Henry Ford Macomb Hospital-Clinton Township
City
Clinton Township
State/Province
Michigan
ZIP/Postal Code
48038
Country
United States
Facility Name
Wayne State University/Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Ascension Saint John Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Michigan State University Clinical Center
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Helen DeVos Children's Hospital at Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Spectrum Health at Butterworth Campus
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Trinity Health Grand Rapids Hospital
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Allegiance Health
City
Jackson
State/Province
Michigan
ZIP/Postal Code
49201
Country
United States
Facility Name
Bronson Methodist Hospital
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
Borgess Medical Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
Sparrow Hospital
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
Trinity Health Muskegon Hospital
City
Muskegon
State/Province
Michigan
ZIP/Postal Code
49444
Country
United States
Facility Name
Lakeland Hospital Niles
City
Niles
State/Province
Michigan
ZIP/Postal Code
49120
Country
United States
Facility Name
Spectrum Health Reed City Hospital
City
Reed City
State/Province
Michigan
ZIP/Postal Code
49677
Country
United States
Facility Name
Beaumont Children's Hospital-Royal Oak
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
Lakeland Medical Center Saint Joseph
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Marie Yeager Cancer Center
City
Saint Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Munson Medical Center
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Facility Name
Henry Ford West Bloomfield Hospital
City
West Bloomfield
State/Province
Michigan
ZIP/Postal Code
48322
Country
United States
Facility Name
Essentia Health Cancer Center
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Children's Hospitals and Clinics of Minnesota - Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
University of Minnesota/Masonic Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Central Care Cancer Center - Bolivar
City
Bolivar
State/Province
Missouri
ZIP/Postal Code
65613
Country
United States
Facility Name
Columbia Regional
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
Siteman Cancer Center at West County Hospital
City
Creve Coeur
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Freeman Health System
City
Joplin
State/Province
Missouri
ZIP/Postal Code
64804
Country
United States
Facility Name
Children's Mercy Hospitals and Clinics
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
The University of Kansas Cancer Center-South
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Research Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64132
Country
United States
Facility Name
University of Kansas Cancer Center - North
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64154
Country
United States
Facility Name
University of Kansas Cancer Center - Lee's Summit
City
Lee's Summit
State/Province
Missouri
ZIP/Postal Code
64064
Country
United States
Facility Name
Delbert Day Cancer Institute at PCRMC
City
Rolla
State/Province
Missouri
ZIP/Postal Code
65401
Country
United States
Facility Name
Mercy Clinic-Rolla-Cancer and Hematology
City
Rolla
State/Province
Missouri
ZIP/Postal Code
65401
Country
United States
Facility Name
Cardinal Glennon Children's Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63104
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Mercy Hospital Saint Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Mercy Hospital Springfield
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
CoxHealth South Hospital
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Children's Hospital and Medical Center of Omaha
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198
Country
United States
Facility Name
Radiation Oncology Centers of Nevada Central
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
GenesisCare USA - Las Vegas
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109
Country
United States
Facility Name
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89135
Country
United States
Facility Name
Summerlin Hospital Medical Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89144
Country
United States
Facility Name
Comprehensive Cancer Centers of Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89148
Country
United States
Facility Name
Renown Regional Medical Center
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
Country
United States
Facility Name
Saint Mary's Regional Medical Center
City
Reno
State/Province
Nevada
ZIP/Postal Code
89503
Country
United States
Facility Name
Radiation Oncology Associates
City
Reno
State/Province
Nevada
ZIP/Postal Code
89509
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Hackensack University Medical Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Morristown Medical Center
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07960
Country
United States
Facility Name
Saint Peter's University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Newark Beth Israel Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Facility Name
Saint Joseph's Regional Medical Center
City
Paterson
State/Province
New Jersey
ZIP/Postal Code
07503
Country
United States
Facility Name
University of New Mexico Cancer Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Montefiore Medical Center-Einstein Campus
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Montefiore Medical Center-Weiler Hospital
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Montefiore Medical Center - Moses Campus
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States
Facility Name
Glens Falls Hospital
City
Glens Falls
State/Province
New York
ZIP/Postal Code
12801
Country
United States
Facility Name
NYU Winthrop Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
The Steven and Alexandra Cohen Children's Medical Center of New York
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Laura and Isaac Perlmutter Cancer Center at NYU Langone
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
NYP/Weill Cornell Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
State University of New York Upstate Medical University
City
Syracuse
State/Province
New York
ZIP/Postal Code
13210
Country
United States
Facility Name
New York Medical College
City
Valhalla
State/Province
New York
ZIP/Postal Code
10595
Country
United States
Facility Name
Mission Hospital
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
UNC Lineberger Comprehensive Cancer Center
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Carolinas Medical Center/Levine Cancer Institute
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Novant Health Presbyterian Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
East Carolina University
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Matthews Radiation Oncology Center
City
Matthews
State/Province
North Carolina
ZIP/Postal Code
28105
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Sanford Broadway Medical Center
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Children's Hospital Medical Center of Akron
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
Facility Name
UHHS-Chagrin Highlands Medical Center
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Indu and Raj Soin Medical Center
City
Beavercreek
State/Province
Ohio
ZIP/Postal Code
45431
Country
United States
Facility Name
Dayton Physicians LLC-Miami Valley South
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Miami Valley Hospital South
City
Centerville
State/Province
Ohio
ZIP/Postal Code
45459
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
Oncology Hematology Care Inc-Kenwood
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45236
Country
United States
Facility Name
Oncology Hematology Care Inc-Blue Ash
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Rainbow Babies and Childrens Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Dayton Children's Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45404
Country
United States
Facility Name
Good Samaritan Hospital - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45406
Country
United States
Facility Name
Miami Valley Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Dayton Physician LLC-Miami Valley Hospital North
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Facility Name
Miami Valley Hospital North
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Facility Name
Armes Family Cancer Center
City
Findlay
State/Province
Ohio
ZIP/Postal Code
45840
Country
United States
Facility Name
Blanchard Valley Hospital
City
Findlay
State/Province
Ohio
ZIP/Postal Code
45840
Country
United States
Facility Name
Orion Cancer Care
City
Findlay
State/Province
Ohio
ZIP/Postal Code
45840
Country
United States
Facility Name
Atrium Medical Center-Middletown Regional Hospital
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005-1066
Country
United States
Facility Name
Dayton Physicians LLC-Atrium
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
Dayton Physicians LLC-Wayne
City
Greenville
State/Province
Ohio
ZIP/Postal Code
45331
Country
United States
Facility Name
Wayne Hospital
City
Greenville
State/Province
Ohio
ZIP/Postal Code
45331
Country
United States
Facility Name
Greater Dayton Cancer Center
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Kettering Medical Center
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Springfield Regional Cancer Center
City
Springfield
State/Province
Ohio
ZIP/Postal Code
45504
Country
United States
Facility Name
Springfield Regional Medical Center
City
Springfield
State/Province
Ohio
ZIP/Postal Code
45505
Country
United States
Facility Name
ProMedica Toledo Hospital/Russell J Ebeid Children's Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Dayton Physicians LLC - Troy
City
Troy
State/Province
Ohio
ZIP/Postal Code
45373
Country
United States
Facility Name
Upper Valley Medical Center
City
Troy
State/Province
Ohio
ZIP/Postal Code
45373
Country
United States
Facility Name
Wright-Patterson Medical Center
City
Wright-Patterson Air Force Base
State/Province
Ohio
ZIP/Postal Code
45433
Country
United States
Facility Name
University of Oklahoma Health Sciences Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Mercy Hospital Oklahoma City
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Oklahoma Cancer Specialists and Research Institute-Tulsa
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74146
Country
United States
Facility Name
Saint Charles Health System
City
Bend
State/Province
Oregon
ZIP/Postal Code
97701
Country
United States
Facility Name
Clackamas Radiation Oncology Center
City
Clackamas
State/Province
Oregon
ZIP/Postal Code
97015
Country
United States
Facility Name
Bay Area Hospital
City
Coos Bay
State/Province
Oregon
ZIP/Postal Code
97420
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Providence Saint Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Legacy Emanuel Children's Hospital
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Lehigh Valley Hospital-Cedar Crest
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18103
Country
United States
Facility Name
Lehigh Valley Hospital - Muhlenberg
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
Geisinger Medical Center
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822
Country
United States
Facility Name
Penn State Children's Hospital
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Drexel University School of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19102
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Fox Chase Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
Saint Christopher's Hospital for Children
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19134
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
Children's Hospital of Pittsburgh of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
Lankenau Medical Center
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Prisma Health Cancer Institute - Spartanburg
City
Boiling Springs
State/Province
South Carolina
ZIP/Postal Code
29316
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Prisma Health Richland Hospital
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Greenville Health System Cancer Institute-Andrews
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
Saint Francis Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29601
Country
United States
Facility Name
BI-LO Charities Children's Cancer Center
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Prisma Health Cancer Institute - Butternut
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Prisma Health Cancer Institute - Faris
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Prisma Health Greenville Memorial Hospital
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Saint Francis Cancer Center
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29607
Country
United States
Facility Name
Prisma Health Cancer Institute - Eastside
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Prisma Health Cancer Institute - Greer
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29650
Country
United States
Facility Name
Prisma Health Cancer Institute - Seneca
City
Seneca
State/Province
South Carolina
ZIP/Postal Code
29672
Country
United States
Facility Name
Sanford USD Medical Center - Sioux Falls
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117-5134
Country
United States
Facility Name
T C Thompson Children's Hospital
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
East Tennessee Childrens Hospital
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37916
Country
United States
Facility Name
Saint Jude Children's Research Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38105
Country
United States
Facility Name
The Children's Hospital at TriStar Centennial
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Vanderbilt University/Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Dell Children's Medical Center of Central Texas
City
Austin
State/Province
Texas
ZIP/Postal Code
78723
Country
United States
Facility Name
Driscoll Children's Hospital
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78411
Country
United States
Facility Name
Medical City Dallas Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
Parkland Memorial Hospital
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
UT Southwestern/Simmons Cancer Center-Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
El Paso Children's Hospital
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Facility Name
Cook Children's Medical Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Covenant Children's Hospital
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
Facility Name
UMC Cancer Center / UMC Health System
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79415
Country
United States
Facility Name
Texas Tech University Health Sciences Center-Lubbock
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79430
Country
United States
Facility Name
Children's Hospital of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78207
Country
United States
Facility Name
Methodist Children's Hospital of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Scott and White Memorial Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Huntsman Cancer Institute/University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Primary Children's Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Facility Name
South Jordan Health Center
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84009
Country
United States
Facility Name
Central Vermont Medical Center/National Life Cancer Treatment
City
Berlin
State/Province
Vermont
ZIP/Postal Code
05602
Country
United States
Facility Name
University of Vermont Medical Center
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
University of Vermont and State Agricultural College
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Facility Name
University of Virginia Cancer Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Children's Hospital of The King's Daughters
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Virginia Commonwealth University/Massey Cancer Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Carilion Children's
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24014
Country
United States
Facility Name
Providence Regional Cancer System-Aberdeen
City
Aberdeen
State/Province
Washington
ZIP/Postal Code
98520
Country
United States
Facility Name
PeaceHealth Saint Joseph Medical Center
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Providence Regional Cancer System-Centralia
City
Centralia
State/Province
Washington
ZIP/Postal Code
98531
Country
United States
Facility Name
Providence Regional Cancer Partnership
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
Swedish Cancer Institute-Issaquah
City
Issaquah
State/Province
Washington
ZIP/Postal Code
98029
Country
United States
Facility Name
Kadlec Clinic Hematology and Oncology
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Facility Name
Providence Regional Cancer System-Lacey
City
Lacey
State/Province
Washington
ZIP/Postal Code
98503
Country
United States
Facility Name
PeaceHealth Saint John Medical Center
City
Longview
State/Province
Washington
ZIP/Postal Code
98632
Country
United States
Facility Name
Seattle Children's Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Swedish Medical Center-Ballard Campus
City
Seattle
State/Province
Washington
ZIP/Postal Code
98107
Country
United States
Facility Name
Kaiser Permanente Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98112
Country
United States
Facility Name
Swedish Medical Center-First Hill
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Providence Sacred Heart Medical Center and Children's Hospital
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States
Facility Name
Madigan Army Medical Center
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98431
Country
United States
Facility Name
PeaceHealth Southwest Medical Center
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States
Facility Name
Providence Saint Mary Regional Cancer Center
City
Walla Walla
State/Province
Washington
ZIP/Postal Code
99362
Country
United States
Facility Name
North Star Lodge Cancer Center at Yakima Valley Memorial Hospital
City
Yakima
State/Province
Washington
ZIP/Postal Code
98902
Country
United States
Facility Name
West Virginia University Charleston Division
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25304
Country
United States
Facility Name
West Virginia University Healthcare
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Aurora Cancer Care-Southern Lakes VLCC
City
Burlington
State/Province
Wisconsin
ZIP/Postal Code
53105
Country
United States
Facility Name
Aurora Health Center-Fond du Lac
City
Fond Du Lac
State/Province
Wisconsin
ZIP/Postal Code
54937
Country
United States
Facility Name
Aurora Health Care Germantown Health Center
City
Germantown
State/Province
Wisconsin
ZIP/Postal Code
53022
Country
United States
Facility Name
Aurora Cancer Care-Grafton
City
Grafton
State/Province
Wisconsin
ZIP/Postal Code
53024
Country
United States
Facility Name
Aurora BayCare Medical Center
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54311
Country
United States
Facility Name
Aurora Cancer Care-Kenosha South
City
Kenosha
State/Province
Wisconsin
ZIP/Postal Code
53142
Country
United States
Facility Name
University of Wisconsin Carbone Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Aurora Bay Area Medical Group-Marinette
City
Marinette
State/Province
Wisconsin
ZIP/Postal Code
54143
Country
United States
Facility Name
Marshfield Medical Center-Marshfield
City
Marshfield
State/Province
Wisconsin
ZIP/Postal Code
54449
Country
United States
Facility Name
Aurora Cancer Care-Milwaukee
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States
Facility Name
Aurora Saint Luke's Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Aurora Sinai Medical Center
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53233
Country
United States
Facility Name
Vince Lombardi Cancer Clinic - Oshkosh
City
Oshkosh
State/Province
Wisconsin
ZIP/Postal Code
54904
Country
United States
Facility Name
Aurora Cancer Care-Racine
City
Racine
State/Province
Wisconsin
ZIP/Postal Code
53406
Country
United States
Facility Name
Vince Lombardi Cancer Clinic-Sheboygan
City
Sheboygan
State/Province
Wisconsin
ZIP/Postal Code
53081
Country
United States
Facility Name
Aurora Medical Center in Summit
City
Summit
State/Province
Wisconsin
ZIP/Postal Code
53066
Country
United States
Facility Name
Vince Lombardi Cancer Clinic-Two Rivers
City
Two Rivers
State/Province
Wisconsin
ZIP/Postal Code
54241
Country
United States
Facility Name
Aurora Cancer Care-Waukesha
City
Waukesha
State/Province
Wisconsin
ZIP/Postal Code
53188
Country
United States
Facility Name
Aurora Cancer Care-Milwaukee West
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Aurora West Allis Medical Center
City
West Allis
State/Province
Wisconsin
ZIP/Postal Code
53227
Country
United States
Facility Name
Cross Cancer Institute
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z2
Country
Canada
Facility Name
British Columbia Children's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3V4
Country
Canada
Facility Name
CancerCare Manitoba
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 0V9
Country
Canada
Facility Name
Janeway Child Health Centre
City
Saint John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
IWK Health Centre
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3K 6R8
Country
Canada
Facility Name
McMaster Children's Hospital at Hamilton Health Sciences
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 3Z5
Country
Canada
Facility Name
Children's Hospital
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada
Facility Name
CIUSSSEMTL-Hopital Maisonneuve-Rosemont
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
CHUM - Hopital Notre-Dame
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
CHUM - Centre Hospitalier de l'Universite de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada
Facility Name
The Montreal Children's Hospital of the MUHC
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1P3
Country
Canada
Facility Name
Centre Hospitalier Universitaire Sainte-Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Facility Name
Allan Blair Cancer Centre
City
Regina
State/Province
Saskatchewan
ZIP/Postal Code
S4T 7T1
Country
Canada
Facility Name
CHU de Quebec-Centre Hospitalier de l'Universite Laval (CHUL)
City
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
Facility Name
San Jorge Children's Hospital
City
San Juan
ZIP/Postal Code
00912
Country
Puerto Rico
Facility Name
University Pediatric Hospital
City
San Juan
ZIP/Postal Code
00926
Country
Puerto Rico

12. IPD Sharing Statement

Citations:
PubMed Identifier
34515544
Citation
Avutu V, Weiss AR, Reed DR, Ahmed SK, Allen-Rhoades WA, Chen YE, Davis LE, Eaton BR, Hawkins DS, Indelicato DJ, Patel SR, Randall RL, Reinke DK, Riedel RF, Scharschmidt TJ, Thornton KA, Wang D, Janeway KA, Kopp LM. Identified Enrollment Challenges of Adolescent and Young Adult Patients on the Nonchemotherapy Arm of Children's Oncology Group Study ARST1321. J Adolesc Young Adult Oncol. 2022 Jun;11(3):328-332. doi: 10.1089/jayao.2021.0103. Epub 2021 Sep 9.
Results Reference
derived
PubMed Identifier
32827353
Citation
Vatner R, James CD, Sathiaseelan V, Bondra KM, Kalapurakal JA, Houghton PJ. Radiation therapy and molecular-targeted agents in preclinical testing for immunotherapy, brain tumors, and sarcomas: Opportunities and challenges. Pediatr Blood Cancer. 2021 May;68 Suppl 2:e28439. doi: 10.1002/pbc.28439. Epub 2020 Aug 22.
Results Reference
derived
PubMed Identifier
32702309
Citation
Weiss AR, Chen YL, Scharschmidt TJ, Chi YY, Tian J, Black JO, Davis JL, Fanburg-Smith JC, Zambrano E, Anderson J, Arens R, Binitie O, Choy E, Davis JW, Hayes-Jordan A, Kao SC, Kayton ML, Kessel S, Lim R, Meyer WH, Million L, Okuno SH, Ostrenga A, Parisi MT, Pryma DA, Randall RL, Rosen MA, Schlapkohl M, Shulkin BL, Smith EA, Sorger JI, Terezakis S, Hawkins DS, Spunt SL, Wang D. Pathological response in children and adults with large unresected intermediate-grade or high-grade soft tissue sarcoma receiving preoperative chemoradiotherapy with or without pazopanib (ARST1321): a multicentre, randomised, open-label, phase 2 trial. Lancet Oncol. 2020 Aug;21(8):1110-1122. doi: 10.1016/S1470-2045(20)30325-9. Epub 2020 Jul 20.
Results Reference
derived

Learn more about this trial

Radiation Therapy With or Without Combination Chemotherapy or Pazopanib Before Surgery in Treating Patients With Newly Diagnosed Non-rhabdomyosarcoma Soft Tissue Sarcomas That Can Be Removed by Surgery

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