Back to results

Observation, Radiation Therapy, Combination Chemotherapy, and/or Surgery in Treating Young Patients With Soft Tissue Sarcoma

Primary Purpose

Adult Alveolar Soft-part Sarcoma, Adult Angiosarcoma, Adult Epithelioid Sarcoma

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

doxorubicin hydrochloride

clinical observation

therapeutic conventional surgery

3-dimensional conformal radiation therapy

ifosfamide

About this trial

This is an interventional treatment trial for Adult Alveolar Soft-part Sarcoma

Eligibility Criteria

undefined - 29 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Newly diagnosed non-rhabdomyosarcoma soft tissue sarcoma (STS), confirmed by central pathology review via concurrent enrollment on protocol COG-D9902 Metastatic or non metastatic disease Meets 1 of the following criteria: Intermediate (i.e., rarely metastasizing) or malignant STS, including any of the following: Adipocytic tumor, including liposarcoma of any of the following histology subtypes: Dedifferentiated Myxoid Round cell Pleomorphic type Mixed-type Not otherwise specified (NOS) Fibroblastic/myofibroblastic tumors, including any of the following: Solitary fibrous tumor Hemangiopericytoma Low-grade myofibroblastic sarcoma Myxoinflammatory fibroblastic sarcoma Adult fibrosarcoma* Myxofibrosarcoma Low-grade fibromyxoid sarcoma or hyalinizing spindle-cell tumor Sclerosing epithelioid fibrosarcoma So-called fibrohistiocytic tumors, including any of the following: Plexiform fibrohistiocytic tumor Giant cell tumor of soft tissues Pleomorphic malignant fibrous histiocytoma (MFH)/undifferentiated pleomorphic sarcoma Giant cell MFH/undifferentiated pleomorphic sarcoma with giant cells Inflammatory MFH/undifferentiated pleomorphic sarcoma with prominent inflammation Smooth muscle tumor (leiomyosarcoma) Pericytic [perivascular] tumor (malignant glomus tumor or glomangiosarcoma) Vascular tumor, including angiosarcoma Chondro-osseous tumors of any of the following types: Mesenchymal chondrosarcoma Extraskeletal osteosarcoma Tumors of uncertain differentiation, including any of the following: Angiomatoid fibrous histiocytoma Ossifying fibromyxoid tumor Myoepithelioma/parachordoma Synovial sarcoma Epithelioid sarcoma Alveolar soft-part sarcoma Clear cell sarcoma of soft tissue Extraskeletal myxoid chondrosarcoma ("chordoid type") Malignant mesenchymoma Neoplasms with perivascular epithelioid cell differentiation (PEComa) Clear cell myomelanocytic tumor Intimal sarcoma Malignant peripheral nerve sheath tumor Dermatofibrosarcoma protuberans meeting both of the following criteria: Non metastatic disease Tumor must be grossly resected prior to study enrollment Embryonal sarcoma of the liver Unclassified STS that is too undifferentiated to be placed in a specific pathologic category (undifferentiated STS or STS NOS) Gross resection of the primary tumor ≤ 42 days prior to enrollment required except if any of the following circumstances apply: Non metastatic high-grade tumor > 5 cm in maximal diameter and gross or microscopic residual tumor is anticipated after resection Tumor of either high- or- low-grade that cannot be grossly excised without unacceptable morbidity High-grade tumor with metastases Patients with metastatic low-grade tumor whose disease is amenable to gross resection at all sites must undergo gross resection of all sites prior to study entry Patients with a tumor recurrence after a gross total resection are not eligible Tumors arising in bone are not eligible Patients with epithelioid sarcoma, clear cell sarcoma, or clinical or radiologic evidence of regional lymph node enlargement must undergo sentinel lymph node biopsies or lymph node sampling to confirm the status of regional lymph nodes* NOTE: *Except in cases where the study radiologist reviews the imaging and indicates that a biopsy is not needed to confirm that the patient has lymph node involvement. If lymph node biopsies are positive for tumor (or the lymph nodes are classified as positive by the study radiologist), formal lymph node dissection must be done at the time of definitive surgery(prior to study entry for patients assigned to study regimen C) Patients with metastatic disease must undergo a biopsy to confirm the presence of metastatic tumor if all metastases are < 1 cm in maximal diameter (except in cases where the study radiologist reviews the imaging and indicated that a biopsy is not needed to confirm that the patient has metastatic disease) Lansky performance status (PS) 50-100% (for patients ≤ 16 years of age) OR Karnofsky PS 50-100% (for patients > 16 years of age) Life expectancy ≥ 3 months Absolute neutrophil count ≥ 1,000/mm³* Platelet count ≥ 100,000/mm³* Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min (≥ 40 mL/min for infants < 1 year of age)* or serum creatinine based on age and/or gender as follows: 0.4 mg/dL (1 month to < 6 months of age) 0.5 mg/dL (6 months to < 1 year of age) 0.6 mg/dL (1 year to < 2 years of age) 0.8 mg/dL (2 years to < 6 years of age) 1.0 mg/dL (6 years to < 10 years of age) 1.2 mg/dL (10 years to < 13 years of age) 1.5 mg/dL (male) or 1.4 mg/dL (female) (13 years to < 16 years of age) 1.7 mg/dL (male) or 1.4 mg/dL (female) (≥ 16 years of age) Patients with urinary tract obstruction by tumor must meet the renal function criteria listed above AND must have unimpeded urinary flow established via decompression of the obstructed portion of the urinary tract Bilirubin ≤ 1.5 times upper limit of normal (ULN)* Shortening fraction ≥ 27% by echocardiogram* OR ejection fraction ≥ 50% by radionuclide angiogram* Not pregnant or nursing (patients undergoing radiotherapy and/or chemotherapy) No nursing for ≥ 1 month after completion of study treatment in study regimens C or D Fertile patients must use effective contraception during and for ≥ 1 month after completion of study treatment Negative pregnancy test No evidence of dyspnea at rest* No exercise intolerance* Resting pulse oximetry reading > 94% on room air (for patients with respiratory symptoms)* Prior treatment for cancer allowed provided the patient meet the prior therapy requirements No prior anthracycline (e.g., doxorubicin or daunorubicin) or ifosfamide chemotherapy for patients enrolled on arm C or arm D No prior radiotherapy to tumor-involved sites

Sites / Locations

University of Alabama at Birmingham
Phoenix Childrens Hospital
University of Arizona Health Sciences Center
University of Arkansas for Medical Sciences
Children's Oncology Group
Southern California Permanente Medical Group
City of Hope Medical Center
Loma Linda University Medical Center
Miller Children's Hospital
Children's Hospital Los Angeles
Cedars-Sinai Medical Center
David Geffen School of Medicine at UCLA
Children's Hospital Central California
Children's Hospital and Research Center at Oakland
Kaiser Permanente-Oakland
Childrens Hospital of Orange County
Lucile Packard Children's Hospital Stanford University
Rady Children's Hospital - San Diego
University of California San Francisco Medical Center-Parnassus
Children's Hospital Colorado
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center
Connecticut Children's Medical Center
Yale University
Alfred I duPont Hospital for Children
Children's National Medical Center
Broward Health Medical Center
Lee Memorial Health System
University of Florida
Memorial Healthcare System - Joe DiMaggio Children's Hospital
Nemours Children's Clinic - Jacksonville
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami Children's Hospital
Baptist Hospital of Miami
Florida Hospital
M D Anderson Cancer Center- Orlando
Nemours Childrens Clinic - Orlando
Nemours Children's Clinic - Pensacola
All Children's Hospital
Saint Joseph Children's Hospital of Tampa
Saint Mary's Hospital
Children's Healthcare of Atlanta - Egleston
Memorial Health University Medical Center
University of Hawaii
Tripler Army Medical Center
Saint Luke's Mountain States Tumor Institute
University of Illinois
Childrens Memorial Hospital
University of Chicago Comprehensive Cancer Center
Loyola University Medical Center
Advocate Hope Children's Hospital
Advocate Lutheran General Hospital
Saint Jude Midwest Affiliate
Southern Illinois University
Riley Hospital for Children
Saint Vincent Hospital and Health Services
University of Iowa Hospitals and Clinics
University of Kentucky
Kosair Children's Hospital
Tulane University Health Sciences Center
Eastern Maine Medical Center
Maine Children's Cancer Program
University of Maryland Greenebaum Cancer Center
Sinai Hospital of Baltimore
Johns Hopkins University
Walter Reed National Military Medical Center
Massachusetts General Hospital Cancer Center
Dana-Farber Cancer Institute
University of Massachusetts Medical School
C S Mott Children's Hospital
Wayne State University
Saint John Hospital and Medical Center
Hurley Medical Center
Helen DeVos Children's Hospital at Spectrum Health
Kalamazoo Center for Medical Studies
Michigan State University - Breslin Cancer Center
Children's Hospitals and Clinics of Minnesota - Minneapolis
University of Minnesota Medical Center-Fairview
Mayo Clinic
University of Mississippi Medical Center
University of Missouri-Columbia
The Childrens Mercy Hospital
Washington University School of Medicine
Saint John's Mercy Medical Center
University of Nebraska Medical Center
Nevada Cancer Research Foundation CCOP
Dartmouth Hitchcock Medical Center
Hackensack University Medical Center
Saint Peter's University Hospital
UMDNJ - Robert Wood Johnson University Hospital
Newark Beth Israel Medical Center
Saint Joseph's Regional Medical Center
Overlook Hospital
University of New Mexico Cancer Center
Albany Medical Center
Montefiore Medical Center
Brooklyn Hospital Center
Roswell Park Cancer Institute
The Steven and Alexandra Cohen Children's Medical Center of New York
New York University Langone Medical Center
Mount Sinai Medical Center
Columbia University Medical Center
University of Rochester
Stony Brook University Medical Center
State University of New York Upstate Medical University
New York Medical College
Mission Hospitals Inc
University of North Carolina
Carolinas Medical Center
Presbyterian Hospital
Duke University Medical Center
Wake Forest University Health Sciences
Sanford Medical Center-Fargo
Children's Hospital Medical Center of Akron
Cincinnati Children's Hospital Medical Center
Rainbow Babies and Childrens Hospital
Cleveland Clinic Foundation
Nationwide Children's Hospital
The Children's Medical Center of Dayton
The Toledo Hospital/Toledo Children's Hospital
Mercy Children's Hospital
University of Oklahoma Health Sciences Center
Legacy Emanuel Children's Hospital
Legacy Emanuel Hospital and Health Center
Oregon Health and Science University
Lehigh Valley Hospital - Muhlenberg
Geisinger Medical Center
Penn State Hershey Children's Hospital
Children's Hospital of Philadelphia
Children's Hospital of Pittsburgh of UPMC
Rhode Island Hospital
Palmetto Health Richland
Greenville Cancer Treatment Center
Sanford USD Medical Center - Sioux Falls
T C Thompson Children's Hospital
East Tennessee Childrens Hospital
St. Jude Children's Research Hospital
Vanderbilt-Ingram Cancer Center
Texas Tech University Health Science Center-Amarillo
Dell Children's Medical Center of Central Texas
Driscoll Children's Hospital
Medical City Dallas Hospital
University of Texas Southwestern Medical Center
Brooke Army Medical Center
Cook Children's Medical Center
Baylor College of Medicine
M D Anderson Cancer Center
Covenant Children's Hospital
University of Texas Health Science Center at San Antonio
Methodist Children's Hospital of South Texas
Scott and White Memorial Hospital
Primary Children's Medical Center
University of Vermont
University of Virginia
Inova Fairfax Hospital
Childrens Hospital-King's Daughters
Virginia Commonwealth University
Seattle Children's Hospital
Providence Sacred Heart Medical Center and Children's Hospital
Mary Bridge Children's Hospital and Health Center
Madigan Army Medical Center
West Virginia University Charleston
Saint Vincent Hospital
University of Wisconsin Hospital and Clinics
Marshfield Clinic
Midwest Children's Cancer Center
Sydney Children's Hospital
The Children's Hospital at Westmead
Royal Brisbane and Women's Hospital
Women's and Children's Hospital-Adelaide
Royal Children's Hospital
Princess Margaret Hospital for Children
Alberta Children's Hospital
University of Alberta Hospital
British Columbia Children's Hospital
CancerCare Manitoba
Janeway Child Health Centre
IWK Health Centre
Chedoke-McMaster Hospitals
Cancer Centre of Southeastern Ontario at Kingston General Hospital
Children's Hospital of Eastern Ontario
Hospital for Sick Children
The Montreal Children's Hospital of the MUHC
Hospital Sainte-Justine
Centre Hospitalier Universitaire de Quebec
Saskatoon Cancer Centre
Starship Children's Hospital
San Jorge Children's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

Arm A: No adjuvant treatment

Arm B: Low risk; adjuvant radiotherapy

Arm C: Intermediate & High risk; adjuvant chemoradiotherapy

Arm D: Intermediate & High Risk; Neoadjuvant chemoradiotherapy

Arm Description

Patients with low-grade tumor with either negative or positive microscopic margins or high-grade tumor ≤ 5 cm (in maximum diameter) with negative microscopic margins are assigned to arm A: (observation only).

Patients with high-grade tumor ≤ 5 cm (in maximum diameter) with positive microscopic margins are assigned to arm B: (adjuvant radiotherapy). Beginning between 6-42 days after surgical resection, patients undergo a total of 31 fractions of adjuvant radiotherapy.

High risk [metastatic, resected, incompletely resected, or unresected disease] patients with high-grade, grossly resected primary tumor, with metastases are assigned to receive arm C: (adjuvant chemoradiotherapy). Patients receive ifosfamide IV; doxorubicin hydrochloride IV; beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy.

High risk [metastatic, resected, incompletely resected, or unresected disease] patients with unresected, high-grade metastatic tumor are assigned to receive treatment as in arm D: (neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy): Patients receive ifosfamide IV; doxorubicin hydrochloride IV. Beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy. Patients undergo surgical resection in week 13.

Outcomes

Primary Outcome Measures

Probability for Event Free Survival.

Probability of no relapse, secondary malignancy or death after 5 years since enrollment.

Secondary Outcome Measures

Toxicity Rate

Percentage of Arm D patients experiencing grade 4+ adverse events.

Complete or Partial Response Rate

Tumor response by imaging. Complete Response (CR): Complete disappearance of the tumor. Partial Response (PR): At least 64% decrease in volume compared to the measurement obtained at study enrollment. Overall Response (OR)=CR+PR.

Percent Tumor Necrosis

Percent tumor necrosis by pathology review.

Event Free Survival Probability Disease Extent

Probability of no relapse, secondary malignancy or death after 5 years since enrollment.

Event Free Survival Probability Histologic Grade

Probability of no relapse, secondary malignancy or death after 5 years since enrollment

Overall Survival Probability Disease Extent

Probability of survival after 5 years since enrollment.

Overall Survival Probability Extent of Resection of the Primary Tumor

Probability of survival after 5 years since enrollment.

Incidence of Distant Metastasis

Percent of patients who had distant metastasis.

Genetic and Gene Expression Profiles

The tumors from patients registered on D9902 will be analyzed for genetic and gene expression profiles. The study will prospectively evaluate each tumor and confirm newly defined sarcoma diagnostic criteria based on cancer signatures in NRSTS.

Degree of Agreement in Histologic Grade Determined by the Enrolling Institution Versus by Central Pathology Reviewers

Histologic grades were determined by the central pathology reviewers and institutional pathologists based on published standards. A higher grade is associated with a more severe disease.

Degree of Agreement in Histologic Grade Between Pediatric Oncology Group (POG) and Fédération Nationale Des Centres de Lutte Contre le Cancer (FNCLCC) Pathologic Grading Systems

POG and FNCLCC grades were determined by pathologists based on published standards. A higher grade is associated with a more severe disease.

Full Information

NCT ID

NCT00346164

First Posted

June 28, 2006

Last Updated

April 1, 2022

Sponsor

Children's Oncology Group

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00346164

Brief Title

Observation, Radiation Therapy, Combination Chemotherapy, and/or Surgery in Treating Young Patients With Soft Tissue Sarcoma

Official Title

Risk-Based Treatment for Non-Rhabdomyosarcoma Soft Tissue Sarcomas (NRSTS) in Patients Under 30 Years of Age

Study Type

Interventional

2. Study Status

Record Verification Date

June 2021

Overall Recruitment Status

Completed

Study Start Date

February 5, 2007 (Actual)

Primary Completion Date

September 5, 2014 (Actual)

Study Completion Date

March 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Children's Oncology Group

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This phase III trial is studying observation to see how well a risk based treatment strategy works in patients with soft tissue sarcoma. In the study, patients are assigned to receive surgery +/- radiotherapy +/- chemotherapy depending on their risk of recurrence. Sometimes, after surgery, the tumor may not need additional treatment until it progresses. In this case, observation may be sufficient. 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 or by stopping them from dividing. Giving chemotherapy and radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving these treatments after surgery may kill any tumor cells that remain after surgery.

Detailed Description

PRIMARY OBJECTIVES: I. Define a risk-based treatment strategy comprising observation only, adjuvant radiotherapy, or adjuvant chemoradiotherapy or neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy in young patients with non-rhabdomyosarcoma soft tissue sarcoma (NRSTS). II. Assess event-free and overall survival of patients treated with these regimens. III. Assess the pattern of treatment failure in these patients. SECONDARY OBJECTIVES: I. Assess the feasibility of a neoadjuvant chemoradiotherapy approach in patients with intermediate- or high-risk NRSTS. II. Assess the imaging and pathologic responses to neoadjuvant chemoradiotherapy in patients with intermediate- or high-risk NRSTS. III. Correlate imaging and pathologic response with clinical outcomes in patients with intermediate- or high-risk disease who undergo neoadjuvant chemoradiotherapy. IV. Prospectively define clinical prognostic factors associated with event-free survival, overall survival, local recurrence, and distant recurrence in these patients. V. Correlate patient outcomes with findings of biologic studies performed on tissue specimens collected on protocol COG-D9902 from these patients. VI. Determine whether the diagnosis and histologic grade of NRSTS assigned by the enrolling institution correlates with the diagnosis and histologic grade established by central expert pathology reviewers. VII. Compare the Pediatric Oncology Group (POG) and Fédération Nationale des Centres de Lutte Contre le Cancer (French Federation of Cancer Centers [FNCLCC]) pathologic grading systems to determine which better correlates with clinical outcomes. OUTLINE: This is a multicenter study. Patients are divided into 3 risk groups according to presence of metastatic disease (yes vs no), status of prior surgery (resected vs unresected), grade of tumor (low vs high), and size of primary tumor (≤ 5 cm vs > 5 cm). Patients are assigned to different treatment regimens based on disease extent (nonmetastatic vs metastatic), tumor size (≤ 5 cm vs > 5 cm), extent of resection of primary tumor (resected vs unresected), extent of resection of metastases (complete or microscopic residual vs gross residual), microscopic tumor margins (negative vs positive), and tumor grade (low vs high). GROUP 1 (low risk [nonmetastatic, grossly resected disease, except high-grade tumor > 5 cm]): Patients with low-grade tumor with either negative or positive microscopic margins or high-grade tumor ≤ 5 cm (in maximum diameter) with negative microscopic margins are assigned to regimen A. Patients with high-grade tumor ≤ 5 cm (in maximum diameter) with positive microscopic margins are assigned to regimen B. REGIMEN A (observation only): Patients undergo observation only. REGIMEN B (adjuvant radiotherapy): Beginning between 6-42 days after surgical resection, patients undergo a total of 31 fractions of adjuvant radiotherapy. GROUP 2 (intermediate risk [nonmetastatic, resected or unresected disease]): Patients with grossly resected, high-grade tumor > 5 cm (in maximum diameter) are assigned to regimen C. Patients with unresected tumor are assigned to regimen D. REGIMEN C (adjuvant chemoradiotherapy): Patients receive ifosfamide IV over 3 hours on days 1-3 in weeks 1, 4, 7, 10, 13, and 16 and doxorubicin hydrochloride IV over 24 hours on days 1 and 2 in weeks 1, 4, 13, 16, and 19. Beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy. *NOTE: *Patients who receive brachytherapy will initiate radiotherapy in Week 1. If brachytherapy is administered, chemotherapy should begin within 2 weeks of completion of brachytherapy and the Weeks 1 and 19 doxorubicin should be given instead at Weeks 7 and 10. REGIMEN D (neoadjuvant chemoradiotherapy, surgery, and adjuvant chemotherapy with or without radiotherapy): Neoadjuvant chemoradiotherapy and surgery: Patients receive ifosfamide IV over 3 hours on days 1-3 in weeks 1, 4, 7, and 10 and doxorubicin hydrochloride IV over 24 hours on days 1 and 2 in weeks 1 and 4. Beginning in week 4, patients also undergo a total of 31 fractions of radiotherapy**. Patients undergo surgical resection in week 13. NOTE: **Patients with primary hepatic tumors do not receive radiotherapy in week 4. Adjuvant chemotherapy with or without radiotherapy: Patients receive ifosfamide IV over 3 hours on days 1-3 in weeks 16 and 19 and doxorubicin hydrochloride IV over 24 hours on days 1 and 2 in weeks 16, 19***, and 22. Beginning in week 16, patients achieving gross total resection with positive microscopic margins undergo a total of 6 fractions of adjuvant radiotherapy. Patients achieving less than total gross resection undergo a total of 11 fractions of adjuvant radiotherapy. Patients achieving total gross resection with negative microscopic margins do not receive adjuvant radiotherapy. NOTE: ***Patients who receive adjuvant radiotherapy in week 16 receive doxorubicin hydrochloride in week 25 instead of week 19. GROUP 3 (high risk [metastatic, resected, incompletely resected, or unresected disease]): Patients with low-grade, all-sites resected tumor with either negative or positive microscopic margins are assigned to receive treatment as in group 1 regimen A. Patients with high-grade, grossly resected primary tumor, and metastatic disease are assigned to receive treatment as in group 2 regimen C. Patients with unresected, high-grade metastatic tumor are assigned to receive treatment as in group 2 regimen D. In all groups, treatment continues in the absence of disease progression. After completing study treatment, patients are followed periodically for at least 5 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adult Alveolar Soft-part Sarcoma, Adult Angiosarcoma, Adult Epithelioid Sarcoma, Adult Extraskeletal Chondrosarcoma, Adult Extraskeletal Osteosarcoma, Adult Fibrosarcoma, Adult Leiomyosarcoma, Adult Liposarcoma, Adult Malignant Fibrous Histiocytoma, Adult Malignant Hemangiopericytoma, Adult Malignant Mesenchymoma, Adult Neurofibrosarcoma, Adult Synovial Sarcoma, Childhood Alveolar Soft-part Sarcoma, Childhood Angiosarcoma, Childhood Epithelioid Sarcoma, Childhood Fibrosarcoma, Childhood Leiomyosarcoma, Childhood Liposarcoma, Childhood Malignant Mesenchymoma, Childhood Neurofibrosarcoma, Childhood Synovial Sarcoma, Dermatofibrosarcoma Protuberans, Metastatic Childhood Soft Tissue Sarcoma, Nonmetastatic Childhood Soft Tissue Sarcoma, Stage I Adult Soft Tissue Sarcoma, Stage II Adult Soft Tissue Sarcoma, Stage III Adult Soft Tissue Sarcoma, Stage IV Adult Soft Tissue Sarcoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

588 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A: No adjuvant treatment

Arm Type

Experimental

Arm Description

Arm Title

Arm B: Low risk; adjuvant radiotherapy

Arm Type

Experimental

Arm Description

Arm Title

Arm C: Intermediate & High risk; adjuvant chemoradiotherapy

Arm Type

Experimental

Arm Description

Arm Title

Arm D: Intermediate & High Risk; Neoadjuvant chemoradiotherapy

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

doxorubicin hydrochloride

Other Intervention Name(s)

ADM, ADR, Adria, Adriamycin PFS, Adriamycin RDF

Intervention Description

Given IV

Intervention Type

Other

Intervention Name(s)

clinical observation

Other Intervention Name(s)

observation

Intervention Description

Patients undergo observation

Intervention Type

Procedure

Intervention Name(s)

therapeutic conventional surgery

Intervention Description

Patients undergo surgery

Intervention Type

Radiation

Intervention Name(s)

3-dimensional conformal radiation therapy

Other Intervention Name(s)

3D conformal radiation therapy, 3D-CRT

Intervention Description

Patients undergo radiotherapy

Intervention Type

Drug

Intervention Name(s)

ifosfamide

Other Intervention Name(s)

Cyfos, Holoxan, IFF, IFX, IPP

Intervention Description

Given IV

Primary Outcome Measure Information:

Title

Probability for Event Free Survival.

Description

Probability of no relapse, secondary malignancy or death after 5 years since enrollment.

Time Frame

5 years

Secondary Outcome Measure Information:

Title

Toxicity Rate

Description

Percentage of Arm D patients experiencing grade 4+ adverse events.

Time Frame

13 weeks

Title

Complete or Partial Response Rate

Description

Time Frame

13 weeks

Title

Percent Tumor Necrosis

Description

Percent tumor necrosis by pathology review.

Time Frame

13 weeks

Title

Event Free Survival Probability Disease Extent

Description

Probability of no relapse, secondary malignancy or death after 5 years since enrollment.

Time Frame

5 years

Title

Event Free Survival Probability Histologic Grade

Description

Probability of no relapse, secondary malignancy or death after 5 years since enrollment

Time Frame

5 years

Title

Overall Survival Probability Disease Extent

Description

Probability of survival after 5 years since enrollment.

Time Frame

5 years

Title

Overall Survival Probability Extent of Resection of the Primary Tumor

Description

Probability of survival after 5 years since enrollment.

Time Frame

5 years

Title

Incidence of Distant Metastasis

Description

Percent of patients who had distant metastasis.

Time Frame

Up to 10 years

Title

Genetic and Gene Expression Profiles

Description

Time Frame

At diagnosis

Title

Degree of Agreement in Histologic Grade Determined by the Enrolling Institution Versus by Central Pathology Reviewers

Description

Histologic grades were determined by the central pathology reviewers and institutional pathologists based on published standards. A higher grade is associated with a more severe disease.

Time Frame

At Diagnosis

Title

Degree of Agreement in Histologic Grade Between Pediatric Oncology Group (POG) and Fédération Nationale Des Centres de Lutte Contre le Cancer (FNCLCC) Pathologic Grading Systems

Description

POG and FNCLCC grades were determined by pathologists based on published standards. A higher grade is associated with a more severe disease.

Time Frame

At diagnosis

10. Eligibility

Sex

All

Maximum Age & Unit of Time

29 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sheri Spunt, MD

Organizational Affiliation

Children's Oncology Group

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Alabama at Birmingham

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35294

Country

United States

Facility Name

Phoenix Childrens Hospital

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85016

Country

United States

Facility Name

University of Arizona Health Sciences Center

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85724

Country

United States

Facility Name

University of Arkansas for Medical Sciences

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

Children's Oncology Group

City

Arcadia

State/Province

California

ZIP/Postal Code

91006-3776

Country

United States

Facility Name

Southern California Permanente Medical Group

City

Downey

State/Province

California

ZIP/Postal Code

90242

Country

United States

Facility Name

City of Hope Medical 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 Hospital

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

Cedars-Sinai Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

Facility Name

David Geffen School of Medicine at UCLA

City

Los Angeles

State/Province

California

ZIP/Postal Code

90095

Country

United States

Facility Name

Children's Hospital Central California

City

Madera

State/Province

California

ZIP/Postal Code

93636-8762

Country

United States

Facility Name

Children's Hospital and Research Center at Oakland

City

Oakland

State/Province

California

ZIP/Postal Code

94609-1809

Country

United States

Facility Name

Kaiser Permanente-Oakland

City

Oakland

State/Province

California

ZIP/Postal Code

94611

Country

United States

Facility Name

Childrens Hospital of Orange County

City

Orange

State/Province

California

ZIP/Postal Code

92868-3874

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

Rady Children's Hospital - San Diego

City

San Diego

State/Province

California

ZIP/Postal Code

92123

Country

United States

Facility Name

University of California San Francisco Medical Center-Parnassus

City

San Francisco

State/Province

California

ZIP/Postal Code

94143

Country

United States

Facility Name

Children's Hospital Colorado

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

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

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

06520-8032

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

Children's National Medical Center

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20010

Country

United States

Facility Name

Broward Health Medical Center

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33316

Country

United States

Facility Name

Lee Memorial Health System

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33901

Country

United States

Facility Name

University of Florida

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32610

Country

United States

Facility Name

Memorial Healthcare System - 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

32207-8426

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

Miami Children's Hospital

City

Miami

State/Province

Florida

ZIP/Postal Code

33155

Country

United States

Facility Name

Baptist Hospital of Miami

City

Miami

State/Province

Florida

ZIP/Postal Code

33176

Country

United States

Facility Name

Florida Hospital

City

Orlando

State/Province

Florida

ZIP/Postal Code

32803

Country

United States

Facility Name

M D Anderson Cancer Center- Orlando

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Nemours Childrens Clinic - Orlando

City

Orlando

State/Province

Florida

ZIP/Postal Code

32806

Country

United States

Facility Name

Nemours Children's Clinic - Pensacola

City

Pensacola

State/Province

Florida

ZIP/Postal Code

32504

Country

United States

Facility Name

All Children's Hospital

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33701

Country

United States

Facility Name

Saint Joseph Children's Hospital of Tampa

City

Tampa

State/Province

Florida

ZIP/Postal Code

33607

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

Children's Healthcare of Atlanta - Egleston

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Memorial Health University Medical Center

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31403

Country

United States

Facility Name

University of Hawaii

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96813

Country

United States

Facility Name

Tripler Army Medical Center

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96859

Country

United States

Facility Name

Saint Luke's Mountain States Tumor Institute

City

Boise

State/Province

Idaho

ZIP/Postal Code

83712

Country

United States

Facility Name

University of Illinois

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60612

Country

United States

Facility Name

Childrens Memorial Hospital

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60614

Country

United States

Facility Name

University of Chicago Comprehensive Cancer Center

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60637-1470

Country

United States

Facility Name

Loyola University Medical Center

City

Maywood

State/Province

Illinois

ZIP/Postal Code

60153

Country

United States

Facility Name

Advocate Hope Children's Hospital

City

Oak Lawn

State/Province

Illinois

ZIP/Postal Code

60453

Country

United States

Facility Name

Advocate Lutheran General Hospital

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

61602

Country

United States

Facility Name

Southern Illinois University

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62702

Country

United States

Facility Name

Riley Hospital for Children

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Facility Name

Saint Vincent Hospital and Health Services

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46260

Country

United States

Facility Name

University of Iowa Hospitals and Clinics

City

Iowa City

State/Province

Iowa

ZIP/Postal Code

52242

Country

United States

Facility Name

University of Kentucky

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40536

Country

United States

Facility Name

Kosair Children's Hospital

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

Tulane University Health Sciences Center

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70112

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

University of Maryland Greenebaum Cancer Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201-1595

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

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287-8936

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

02115

Country

United States

Facility Name

University of Massachusetts Medical School

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

Wayne State University

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48202

Country

United States

Facility Name

Saint John Hospital and Medical Center

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48236

Country

United States

Facility Name

Hurley Medical Center

City

Flint

State/Province

Michigan

ZIP/Postal Code

48502

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

Kalamazoo Center for Medical Studies

City

Kalamazoo

State/Province

Michigan

ZIP/Postal Code

49008

Country

United States

Facility Name

Michigan State University - Breslin Cancer Center

City

Lansing

State/Province

Michigan

ZIP/Postal Code

48910

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 Medical Center-Fairview

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

Facility Name

Mayo Clinic

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

University of Missouri-Columbia

City

Columbia

State/Province

Missouri

ZIP/Postal Code

65212

Country

United States

Facility Name

The Childrens Mercy Hospital

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64108

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

Saint John's Mercy Medical Center

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

University of Nebraska Medical Center

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68198

Country

United States

Facility Name

Nevada Cancer Research Foundation CCOP

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89106

Country

United States

Facility Name

Dartmouth Hitchcock Medical 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

Saint Peter's University Hospital

City

New Brunswick

State/Province

New Jersey

ZIP/Postal Code

08901

Country

United States

Facility Name

UMDNJ - 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

Overlook Hospital

City

Summit

State/Province

New Jersey

ZIP/Postal Code

07902

Country

United States

Facility Name

University of New Mexico Cancer Center

City

Albuquerque

State/Province

New Mexico

ZIP/Postal Code

87106

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

City

Bronx

State/Province

New York

ZIP/Postal Code

10467-2490

Country

United States

Facility Name

Brooklyn Hospital Center

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11201

Country

United States

Facility Name

Roswell Park Cancer Institute

City

Buffalo

State/Province

New York

ZIP/Postal Code

14263

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

New York University Langone Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Facility Name

Mount Sinai Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10029

Country

United States

Facility Name

Columbia University Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10032

Country

United States

Facility Name

University of Rochester

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

Facility Name

Stony Brook University Medical Center

City

Stony Brook

State/Province

New York

ZIP/Postal Code

11794

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 Hospitals Inc

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

28801

Country

United States

Facility Name

University of North Carolina

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

Facility Name

Carolinas Medical Center

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28203

Country

United States

Facility Name

Presbyterian Hospital

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

Wake Forest University Health Sciences

City

Winston-Salem

State/Province

North Carolina

ZIP/Postal Code

27157

Country

United States

Facility Name

Sanford Medical Center-Fargo

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

Cincinnati Children's Hospital Medical Center

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45229

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

The Children's Medical Center of Dayton

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45404

Country

United States

Facility Name

The Toledo Hospital/Toledo Children's Hospital

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43606

Country

United States

Facility Name

Mercy Children's Hospital

City

Toledo

State/Province

Ohio

ZIP/Postal Code

43608

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

Legacy Emanuel Children's Hospital

City

Portland

State/Province

Oregon

ZIP/Postal Code

97227

Country

United States

Facility Name

Legacy Emanuel Hospital and Health Center

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 - 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

17822-2001

Country

United States

Facility Name

Penn State Hershey Children's Hospital

City

Hershey

State/Province

Pennsylvania

ZIP/Postal Code

17033

Country

United States

Facility Name

Children's Hospital of Philadelphia

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

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

Rhode Island Hospital

City

Providence

State/Province

Rhode Island

ZIP/Postal Code

02903

Country

United States

Facility Name

Palmetto Health Richland

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29203

Country

United States

Facility Name

Greenville Cancer Treatment Center

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29605

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

St. Jude Children's Research Hospital

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38105

Country

United States

Facility Name

Vanderbilt-Ingram Cancer Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37232

Country

United States

Facility Name

Texas Tech University Health Science Center-Amarillo

City

Amarillo

State/Province

Texas

ZIP/Postal Code

79106

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

University of Texas Southwestern Medical Center

City

Dallas

State/Province

Texas

ZIP/Postal Code

75390

Country

United States

Facility Name

Brooke Army Medical Center

City

Fort Sam Houston

State/Province

Texas

ZIP/Postal Code

78234

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

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

University of Texas Health Science Center at San Antonio

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229-3900

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

Scott and White Memorial Hospital

City

Temple

State/Province

Texas

ZIP/Postal Code

76508

Country

United States

Facility Name

Primary Children's Medical Center

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84113

Country

United States

Facility Name

University of Vermont

City

Burlington

State/Province

Vermont

ZIP/Postal Code

05401

Country

United States

Facility Name

University of Virginia

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

Childrens Hospital-King's Daughters

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23507

Country

United States

Facility Name

Virginia Commonwealth University

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23298

Country

United States

Facility Name

Seattle Children's Hospital

City

Seattle

State/Province

Washington

ZIP/Postal Code

98105

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

Mary Bridge Children's Hospital and Health Center

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Facility Name

Madigan Army Medical Center

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98431

Country

United States

Facility Name

West Virginia University Charleston

City

Charleston

State/Province

West Virginia

ZIP/Postal Code

25304

Country

United States

Facility Name

Saint Vincent Hospital

City

Green Bay

State/Province

Wisconsin

ZIP/Postal Code

54301

Country

United States

Facility Name

University of Wisconsin Hospital and Clinics

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792

Country

United States

Facility Name

Marshfield Clinic

City

Marshfield

State/Province

Wisconsin

ZIP/Postal Code

54449

Country

United States

Facility Name

Midwest Children's Cancer Center

City

Milwaukee

State/Province

Wisconsin

ZIP/Postal Code

53226

Country

United States

Facility Name

Sydney Children's Hospital

City

Randwick

State/Province

New South Wales

ZIP/Postal Code

2031

Country

Australia

Facility Name

The Children's Hospital at Westmead

City

Sydney

State/Province

New South Wales

ZIP/Postal Code

2145

Country

Australia

Facility Name

Royal Brisbane and Women's Hospital

City

Herston

State/Province

Queensland

ZIP/Postal Code

4029

Country

Australia

Facility Name

Women's and Children's Hospital-Adelaide

City

North Adelaide

State/Province

South Australia

ZIP/Postal Code

5006

Country

Australia

Facility Name

Royal Children's Hospital

City

Parkville

State/Province

Victoria

ZIP/Postal Code

3052

Country

Australia

Facility Name

Princess Margaret Hospital for Children

City

Perth

State/Province

Western Australia

ZIP/Postal Code

6008

Country

Australia

Facility Name

Alberta Children's Hospital

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T3B 6A8

Country

Canada

Facility Name

University of Alberta Hospital

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2B7

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

B3J 3G9

Country

Canada

Facility Name

Chedoke-McMaster Hospitals

City

Hamilton

State/Province

Ontario

ZIP/Postal Code

L8S 4L8

Country

Canada

Facility Name

Cancer Centre of Southeastern Ontario at Kingston General Hospital

City

Kingston

State/Province

Ontario

ZIP/Postal Code

K7L 5P9

Country

Canada

Facility Name

Children's Hospital of Eastern Ontario

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L1

Country

Canada

Facility Name

Hospital for Sick Children

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5G 1X8

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

Hospital Sainte-Justine

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1C5

Country

Canada

Facility Name

Centre Hospitalier Universitaire de Quebec

City

Ste-Foy

State/Province

Quebec

ZIP/Postal Code

G1V 4G2

Country

Canada

Facility Name

Saskatoon Cancer Centre

City

Saskatoon

State/Province

Saskatchewan

ZIP/Postal Code

S7N 4H4

Country

Canada

Facility Name

Starship Children's Hospital

City

Grafton

State/Province

Auckland

ZIP/Postal Code

1145

Country

New Zealand

Facility Name

San Jorge Children's Hospital

City

Santurce

ZIP/Postal Code

00912

Country

Puerto Rico

12. IPD Sharing Statement

Citations:

PubMed Identifier

34623899

Citation

Venkatramani R, Xue W, Randall RL, Wolden S, Anderson J, Lopez-Terrada D, Black J, Kao SC, Shulkin B, Ostrenga A, Pappo A, Spunt SL. Synovial Sarcoma in Children, Adolescents, and Young Adults: A Report From the Children's Oncology Group ARST0332 Study. J Clin Oncol. 2021 Dec 10;39(35):3927-3937. doi: 10.1200/JCO.21.01628. Epub 2021 Oct 8.

Results Reference

derived

PubMed Identifier

33548339

Citation

Million L, Hayes-Jordan A, Chi YY, Donaldson SS, Wolden S, Morris C, Terezakis S, Laurie F, Morano K, Fitzgerald TJ, Yock TI, Rodeberg DA, Anderson JR, Speights RA, Black JO, Coffin C, McCarville MB, Kao SC, Hawkins DS, Spunt SL, Randall RL. Local Control For High-Grade Nonrhabdomyosarcoma Soft Tissue Sarcoma Assigned to Radiation Therapy on ARST0332: A Report From the Childrens Oncology Group. Int J Radiat Oncol Biol Phys. 2021 Jul 1;110(3):821-830. doi: 10.1016/j.ijrobp.2021.01.051. Epub 2021 Feb 3.

Results Reference

derived

PubMed Identifier

31786124

Citation

Spunt SL, Million L, Chi YY, Anderson J, Tian J, Hibbitts E, Coffin C, McCarville MB, Randall RL, Parham DM, Black JO, Kao SC, Hayes-Jordan A, Wolden S, Laurie F, Speights R, Kawashima E, Skapek SX, Meyer W, Pappo AS, Hawkins DS. A risk-based treatment strategy for non-rhabdomyosarcoma soft-tissue sarcomas in patients younger than 30 years (ARST0332): a Children's Oncology Group prospective study. Lancet Oncol. 2020 Jan;21(1):145-161. doi: 10.1016/S1470-2045(19)30672-2. Epub 2019 Nov 27.

Results Reference

derived

PubMed Identifier

30954717

Citation

Spunt SL, Francotte N, De Salvo GL, Chi YY, Zanetti I, Hayes-Jordan A, Kao SC, Orbach D, Brennan B, Weiss AR, van Noesel MM, Million L, Alaggio R, Parham DM, Kelsey A, Randall RL, McCarville MB, Bisogno G, Hawkins DS, Ferrari A. Clinical features and outcomes of young patients with epithelioid sarcoma: an analysis from the Children's Oncology Group and the European paediatric soft tissue Sarcoma Study Group prospective clinical trials. Eur J Cancer. 2019 May;112:98-106. doi: 10.1016/j.ejca.2019.02.001. Epub 2019 Apr 5.

Results Reference

derived

PubMed Identifier

28391003

Citation

Ferrari A, Chi YY, De Salvo GL, Orbach D, Brennan B, Randall RL, McCarville MB, Black JO, Alaggio R, Hawkins DS, Bisogno G, Spunt SL. Surgery alone is sufficient therapy for children and adolescents with low-risk synovial sarcoma: A joint analysis from the European paediatric soft tissue sarcoma Study Group and the Children's Oncology Group. Eur J Cancer. 2017 Jun;78:1-6. doi: 10.1016/j.ejca.2017.03.003. Epub 2017 Apr 7.

Results Reference

derived

Links:

URL

https://nctn-data-archive.nci.nih.gov/

Description

Data Available: Select individual patient-level data from this trial can be requested from the NCTN/NCORP Data Archive

Learn more about this trial

Observation, Radiation Therapy, Combination Chemotherapy, and/or Surgery in Treating Young Patients With Soft Tissue Sarcoma

We'll reach out to this number within 24 hrs