Back to resultsHigh-Dose Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Metastatic Rhabdomyosarcoma or Ectomesenchymoma
Primary Purpose
Sarcoma
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
dactinomycin
cyclophosphamide
doxorubicin hydrochloride
etoposide
ifosfamide
irinotecan hydrochloride
vincristine sulfate
conventional surgery
radiation therapy
filgrastim
Sponsored by
About this trial
This is an interventional treatment trial for Sarcoma focused on measuring adult rhabdomyosarcoma, previously untreated childhood rhabdomyosarcoma, adult malignant mesenchymoma, childhood malignant mesenchymoma, metastatic childhood soft tissue sarcoma, stage IV adult soft tissue sarcoma
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed high-risk rhabdomyosarcoma or ectomesenchymoma Prior enrollment on COG-D9902 to confirm local histological diagnosis required Tissue must be submitted for pathologic review within 2 days of patient registration on COG-D9902 Newly diagnosed disease Metastatic disease (stage IV, clinical group IV) Has undergone initial surgical procedure (including biopsy) that provided the definitive diagnosis within the past 42 days Parameningeal and paraspinal tumors allowed Patients with parameningeal (without intracranial extension [ICE]) and paraspinal tumors should begin study chemotherapy at week 1 and radiotherapy at week 20 Patients with evidence of ICE, as defined by contrast MRI showing that primary tumor touches, displaces, invades, distorts, or otherwise causes a signal abnormality of the dura in contiguity to the primary site in brain or spinal cord, are eligible ICE is presumed to exist if the cerebrospinal fluid cytopathology is positive for tumor at diagnosis Patients requiring emergency radiotherapy are eligible Patients requiring emergency radiotherapy (for intracranial extension or spinal cord impingement) should begin study chemotherapy at week 1 (irinotecan hydrochloride and vincristine) concurrently with radiation therapy PATIENT CHARACTERISTICS: ECOG or Zubrod performance status (PS) 0-2 (Lansky PS 50-100% for patients < 10 years of age and Karnofsky PS 50-100% for patients ≥ 10 years of age) Absolute neutrophil count ≥ 750/mm³* Platelet count ≥ 75,000/mm³* Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min (≥ 40 mL/min for infants < 1 year 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 SGPT < 2.5 times normal Bilirubin < 1.5 mg/dL Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by MUGA Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during study and for ≥ 1 month after study completion No evidence of uncontrolled infection Able to undergo radiotherapy NOTE: *Abnormal blood counts allowed if there is bone marrow biopsy or aspirate proven bone marrow involvement by rhabdomyosarcoma PRIOR CONCURRENT THERAPY: No prior chemotherapy except steroids No prior radiotherapy No concurrent aprepitant during ifosfamide or doxorubicin hydrochloride chemotherapy No concurrent dexrazoxane No concurrent sargramostim (GM-CSF) or pegfilgrastim
Sites / Locations
- Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
- Phoenix Children's Hospital
- Arizona Cancer Center at University of Arizona Health Sciences Center
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Southern California Permanente Medical Group
- Loma Linda University Cancer Institute at Loma Linda University Medical Center
- Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
- Childrens Hospital Los Angeles
- Children's Hospital Central California
- Children's Hospital and Research Center Oakland
- Children's Hospital of Orange County
- Sutter Cancer Center
- University of California Davis Cancer Center
- Kaiser Permanente Medical Center - Oakland
- Rady Children's Hospital - San Diego
- UCSF Helen Diller Family Comprehensive Cancer Center
- Stanford Cancer Center
- Children's Hospital Center for Cancer and Blood Disorders
- Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
- Alfred I. duPont Hospital for Children
- Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
- Children's National Medical Center
- Walter Reed Army Medical Center
- Broward General Medical Center Cancer Center
- Lee Cancer Care of Lee Memorial Health System
- University of Florida Shands Cancer Center
- Memorial Cancer Institute at Memorial Regional Hospital
- Nemours Children's Clinic
- Miami Children's Hospital
- Baptist-South Miami Regional Cancer Program
- Florida Hospital Cancer Institute at Florida Hospital Orlando
- M.D. Anderson Cancer Center at Orlando
- Nemours Children's Clinic - Orlando
- Sacred Heart Cancer Center at Sacred Heart Hospital
- All Children's Hospital
- St. Joseph's Cancer Institute at St. Joseph's Hospital
- Kaplan Cancer Center at St. Mary's Medical Center
- Winship Cancer Institute of Emory University
- MBCCOP - Medical College of Georgia Cancer Center
- Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
- Cancer Research Center of Hawaii
- University of Illinois Cancer Center
- Children's Memorial Hospital - Chicago
- University of Chicago Cancer Research Center
- Advocate Christ Medical Center
- Advocate Lutheran General Cancer Care Center
- Saint Jude Midwest Affiliate
- Simmons Cooper Cancer Institute
- Indiana University Melvin and Bren Simon Cancer Center
- St. Vincent Indianapolis Hospital
- Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
- Lucille P. Markey Cancer Center at University of Kentucky
- Kosair Children's Hospital
- Tulane Cancer Center Office of Clinical Research
- Children's Hospital of New Orleans
- Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
- Floating Hospital for Children at Tufts - New England Medical Center
- Massachusetts General Hospital
- Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
- C.S. Mott Children's Hospital at University of Michigan Medical Center
- Barbara Ann Karmanos Cancer Institute
- Hurley Medical Center
- Butterworth Hospital at Spectrum Health
- CCOP - Kalamazoo
- Breslin Cancer Center at Ingham Regional Medical Center
- Children's Hospitals and Clinics of Minnesota - Minneapolis
- University of Minnesota Cancer Center
- Mayo Clinic Cancer Center
- University of Mississippi Cancer Clinic
- Children's Mercy Hospital
- Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint Louis
- Children's Hospital
- UNMC Eppley Cancer Center at the University of Nebraska Medical Center
- Sunrise Hospital and Medical Center
- Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
- Hackensack University Medical Center Cancer Center
- Overlook Hospital
- Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
- Newark Beth Israel Medical Center
- St. Joseph's Hospital and Medical Center
- University of New Mexico Cancer Center
- Albany Medical Center Hospital
- Roswell Park Cancer Institute
- Schneider Children's Hospital
- NYU Cancer Institute at New York University Medical Center
- Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
- James P. Wilmot Cancer Center at University of Rochester Medical Center
- Stony Brook University Cancer Center
- SUNY Upstate Medical University Hospital
- New York Medical College
- Mission Hospitals - Memorial Campus
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
- Blumenthal Cancer Center at Carolinas Medical Center
- Presbyterian Cancer Center at Presbyterian Hospital
- Duke Comprehensive Cancer Center
- Wake Forest University Comprehensive Cancer Center
- Akron Children's Hospital
- Cincinnati Children's Hospital Medical Center
- Rainbow Babies and Children's Hospital
- Cleveland Clinic Taussig Cancer Center
- Nationwide Children's Hospital
- Children's Medical Center - Dayton
- Toledo Hospital
- Medical University of Ohio Cancer Center
- Oklahoma University Cancer Institute
- Oregon Health and Science University Cancer Institute
- Lehigh Valley Hospital - Muhlenberg
- Geisinger Cancer Institute at Geisinger Health
- Penn State Cancer Institute at Milton S. Hershey Medical Center
- Children's Hospital of Philadelphia
- Children's Hospital of Pittsburgh
- Hollings Cancer Center at Medical University of South Carolina
- Palmetto Health South Carolina Cancer Center
- Greenville Hospital Cancer Center
- Sanford Cancer Center at Sanford USD Medical Center
- T.C. Thompson Children's Hospital
- East Tennessee Children's Hospital
- St. Jude Children's Research Hospital
- Vanderbilt-Ingram Cancer Center
- Texas Tech University Health Sciences Center School of Medicine - Amarillo
- Dell Children's Medical Center of Central Texas
- Driscoll Children's Hospital
- Medical City Dallas Hospital
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
- Cook Children's Medical Center - Fort Worth
- Baylor University Medical Center - Houston
- M. D. Anderson Cancer Center at University of Texas
- Covenant Children's Hospital
- University of Texas Health Science Center at San Antonio
- Methodist Children's Hospital of South Texas
- CCOP - Scott and White Hospital
- Primary Children's Medical Center
- Fletcher Allen Health Care - University Health Center Campus
- Inova Fairfax Hospital
- Children's Hospital of The King's Daughters
- Carilion Medical Center for Children at Roanoke Community Hospital
- Children's Hospital and Regional Medical Center - Seattle
- Providence Cancer Center at Sacred Heart Medical Center
- Mary Bridge Children's Hospital and Health Center - Tacoma
- West Virginia University Health Sciences Center - Charleston
- Marshfield Clinic - Marshfield Center
- Midwest Children's Cancer Center
- John Hunter Hospital
- Westmead Institute for Cancer Research at Westmead Hospital
- Royal Children's Hospital
- Women's and Children's Hospital
- Royal Children's Hospital
- Princess Margaret Hospital for Children
- Alberta Children's Hospital
- University of Alberta Hospital
- Children's & Women's Hospital of British Columbia
- CancerCare Manitoba
- Janeway Children's Health and Rehabilitation Centre
- IWK Health Centre
- McMaster Children's Hospital at Hamilton Health Sciences
- Cancer Centre of Southeastern Ontario at Kingston General Hospital
- Children's Hospital of Western Ontario
- Children's Hospital of Eastern Ontario
- Hospital for Sick Children
- Montreal Children's Hospital at McGill University Health Center
- Hopital Sainte Justine
- Saskatoon Cancer Centre at the University of Saskatchewan
- Centre Hospitalier Universitaire de Quebec
- San Jorge Children's Hospital
- Swiss Pediatric Oncology Group Bern
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
High Risk Rhabdomyosarcoma
Arm Description
Parameningeal (without intracranial extension) and paraspinal tumors receive chemotherapy starting Week 1 and begin radiation therapy at Week 20. Weeks 1-6: vincristine sulfate and irinotecan hydrochloride. Weeks 7-34: vincristine sulfate and irinotecan hydrochloride, Cyclophosphamide with MESNA, Doxorubicin hydrochloride, Etoposide, Ifosfamide with MESNA. Weeks 35-54: vincristine sulfate, Dactinomycin, irinotecan hydrochloride and Cyclophosphamide with MESNA and Filgrastim. Radiation therapy beginning at Week 20. Second look conventional surgery: Surgical resection other than biopsy will be applicable for the majority of patients.
Outcomes
Primary Outcome Measures
Number of Patients With Complete or Partial Response Assessed by RECIST Criteria
Volumetric measurements of the primary tumor using an elliptical model (0.5 x the product of the 3 largest perpendicular diameters) to assess response to neoadjuvant therapy. The RECIST (Response Evaluation Criteria in Solid Tumors) from the NCI will be used for assessment of the size of measurable metastases, including nodal metastases. Primary Tumor Measurement: Technical guidelines for cross-sectional imaging computed tomography (CT) slice thickness should be 5mm or less and the diameter of the "measurable" mass should be at least twice the reconstructed slice thickness. Smaller masses are considered detectable, but will be counted as "non-measurable." Complete Response (CR): Complete disappearance of the tumor confirmed at >4 weeks. Partial Response (PR): At least 64% decrease in volume compared to the measurement obtained at study enrollment. Progressive Disease (PD): At least 40% increase in tumor volume compared to the smallest volume obtained since the beginning.
Percentage of Patients Experiencing Adverse Events Due to Concurrent Therapy
Adverse events are reported for patients receiving concurrent irinotecan hydrochloride and radiotherapy.
Secondary Outcome Measures
Percentage of Patients Event Free at 4 Years Following Study Entry
Event-free survival: Time to recurrence, second malignancy, or death as a first event, estimated from a Kaplan Meier curve
Full Information
NCT ID
NCT00354744
First Posted
July 19, 2006
Last Updated
January 15, 2020
Sponsor
Children's Oncology Group
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT00354744
Brief Title
High-Dose Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Metastatic Rhabdomyosarcoma or Ectomesenchymoma
Official Title
Intensive Multi-Agent Therapy, Including Dose-Compressed Cycles of Ifosfamide/Etoposide (IE) and Vincristine/Doxorubicin/Cyclophosphamide (VDC) for Patients With High-Risk Rhabdomyosarcoma
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
July 2006 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
June 30, 2019 (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
RATIONALE: Drugs used in chemotherapy, such as vincristine, irinotecan, ifosfamide, etoposide, doxorubicin, cyclophosphamide, and dactinomycin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving high-dose combination chemotherapy together with radiation therapy may kill more tumor cells.
PURPOSE: This phase III trial is studying how well giving high-dose combination chemotherapy together with radiation therapy works in treating patients with newly diagnosed metastatic rhabdomyosarcoma or ectomesenchymoma.
Detailed Description
OBJECTIVES:
Primary
Improve the early disease control interval for patients with newly diagnosed, high-risk, metastatic rhabdomyosarcoma or ectomesenchymoma using intensive, interval-compression therapy (comprising vincristine, irinotecan hydrochloride, ifosfamide, etoposide, doxorubicin hydrochloride, cyclophosphamide, and dactinomycin) that permits maximal early exposure to known effective agents.
Determine the feasibility and assess immediate- and short-term side effects of concurrent irinotecan hydrochloride and radiotherapy in these patients.
Secondary
Expand the available data for response to irinotecan hydrochloride and vincristine in previously untreated patients with high-risk rhabdomyosarcoma.
Evaluate, prospectively, and validate gene expression values with the intent to define the best diagnostic predictors and more powerful prognostic classifiers.
OUTLINE: This is a prospective, nonrandomized, multicenter study. Patients are stratified according to prognostic factors predictive of outcome (e.g. histology, bone/bone marrow involvement, and number of metastatic sites).
Patients receive high-dose chemotherapy comprising vincristine IV over 1 minute on day 1 of weeks 1-5, 7, 8, 11, 12, 15, 16, 20-24, 28, 29, 32, 33, 35, 38, 41-44, 47, 48, 50, and 51; irinotecan hydrochloride IV over 1 hour on days 1-5 of weeks 1, 4, 20, 23, 47, and 50; and ifosfamide IV over 1 hour and etoposide IV over 30-60 minutes on days 1-5 of weeks 9, 13, 17, 26, and 30. Patients also receive doxorubicin hydrochloride IV continuously over 24 hours on days 1 and 2 of weeks 7*, 11, 15, 28, and 32; cyclophosphamide IV over 30-60 minutes on day 1 of weeks 7, 11, 15, 28, 32, 35, 38, 41, and 44; and dactinomycin IV over 1-5 minutes on day 1 of weeks 35, 38, 41, and 44 in the absence of disease progression or unacceptable toxicity. Patients also receive filgrastim (G-CSF) subcutaneously in weeks 7-9, 11-13, 15-17, 22, 26, 28-30, 32, 33, 35, 38, and 41-44 beginning 24-36 hours after the last chemotherapy dose and continuing until blood counts recover.
NOTE: *Patients undergoing early radiotherapy for intracranial extension do not receive doxorubicin in week 7.
Beginning at week 20 (or week 1 for patients with parameningeal tumors with intracranial extension [or spinal cord compression] requiring emergency radiotherapy), patients also undergo radiotherapy once a day, 5 days a week, for approximately 5½ weeks. Some patients may also undergo second-look surgery.
After completion of study treatment, patients are followed periodically for ≥ 10 years.
PROJECTED ACCRUAL: A total of 75 patients will be accrued for this study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sarcoma
Keywords
adult rhabdomyosarcoma, previously untreated childhood rhabdomyosarcoma, adult malignant mesenchymoma, childhood malignant mesenchymoma, metastatic childhood soft tissue sarcoma, stage IV adult soft tissue sarcoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
109 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Risk Rhabdomyosarcoma
Arm Type
Experimental
Arm Description
Parameningeal (without intracranial extension) and paraspinal tumors receive chemotherapy starting Week 1 and begin radiation therapy at Week 20. Weeks 1-6: vincristine sulfate and irinotecan hydrochloride. Weeks 7-34: vincristine sulfate and irinotecan hydrochloride, Cyclophosphamide with MESNA, Doxorubicin hydrochloride, Etoposide, Ifosfamide with MESNA. Weeks 35-54: vincristine sulfate, Dactinomycin, irinotecan hydrochloride and Cyclophosphamide with MESNA and Filgrastim. Radiation therapy beginning at Week 20. Second look conventional surgery: Surgical resection other than biopsy will be applicable for the majority of patients.
Intervention Type
Biological
Intervention Name(s)
dactinomycin
Other Intervention Name(s)
Actinomycin-D, Cosmegen, NSC #3053
Intervention Description
Age based dosage: ≥ 1 year 0.045 mg/kg IV x 1(maximum dose 2.5 mg), < 1 year 0.025 mg/kg.
Day 1 of Weeks 35, 38, 41 and 44.
Given IV
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Other Intervention Name(s)
Cytoxan, NSC #26271
Intervention Description
Age based dosage: ≥ 3 years 1200 mg/m2, <3 years 40 mg/kg.
Day 1 of weeks 7, 11, 15, 28, 32, 35, 38, 41 and 44.
Given IV
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Other Intervention Name(s)
Adriamycin, NSC #123127
Intervention Description
Age based dosage: ≥ 1 year: 37.5mg/m²/day, < 1 year: treat with 50% doses calculated on a m2 basis. Total dose 75 mg/m².
Days 1 and 2 of weeks 7, 11, 15, 28 and 32.
Given IV
Intervention Type
Drug
Intervention Name(s)
etoposide
Other Intervention Name(s)
VePesid, Etopophos, VP-16, NSC #141540
Intervention Description
Age based dosage: ≥ 1 year: 100 mg/m²/day, < 1 year: treat with 50% doses calculated on a m2 basis.
Days 1-5 of weeks 9, 13, 17, 26 and 30.
Given IV
Intervention Type
Drug
Intervention Name(s)
ifosfamide
Other Intervention Name(s)
Isophosphamide, Iphosphamide, Z4942, Ifex, NSC #109724
Intervention Description
Age based dosage: ≥ 1 year: 1800 mg/m²/day, < 1 year: treat with 50% doses calculated on a m2 basis.
Days 1-5 of weeks 9, 13, 17, 26 and 30.
Given IV
Intervention Type
Drug
Intervention Name(s)
irinotecan hydrochloride
Other Intervention Name(s)
CPT-11, Camptothecin-11, 7-ethyl-10-(4-[1-piperidino]-1-piperidino)-carbonyloxy-camptothecin, Camptosar, NSC #616348
Intervention Description
Dosage 50 mg/m2-max dose 100 mg/day.
Days 1-5 of weeks 1, 4, 20, 23, 47 and 50.
Given IV
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
Other Intervention Name(s)
Oncovin, VCR, LCR, NSC #67574
Intervention Description
Age based dosage: ≥ 3 years 1.5 mg/m2 (max dose 2 mg), ≥ 1 year and < 3 years 0.05 mg/kg (max dose 2 mg), < 1 year 0.025 mg/kg.
Days 1-5 of weeks 1, 2, 3, 4, 5, 7, 8, 11, 12, 15, 16, 20, 21, 22, 23, 24, 28, 29, 32, 33, 35, 38, 41, 42, 43, 44, 47, 48, 50, and 51.
Given IV
Intervention Type
Procedure
Intervention Name(s)
conventional surgery
Intervention Description
Resection of the primary tumor with a surrounding "envelope" of normal tissue
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Intervention Description
Radiotherapy beginning at Week 20 to the primary tumor and to the metastatic sites excepting those with parameningeal tumors with intracranial extension (direct extension into the brain) and those requiring emergency radiotherapy
Intervention Type
Biological
Intervention Name(s)
filgrastim
Other Intervention Name(s)
Granulocyte Colony-Stimulating Factor, r-metHuG-CSF, G-CSF, Neupogen, NSC #614629
Intervention Description
5 micrograms/kg/day (max 300 micrograms) beginning 24-36 hours after the last dose of chemotherapy. Continue at least 7 days, or until the ANC ≥750/μL whichever comes last.
Given subcutaneously.
Primary Outcome Measure Information:
Title
Number of Patients With Complete or Partial Response Assessed by RECIST Criteria
Description
Volumetric measurements of the primary tumor using an elliptical model (0.5 x the product of the 3 largest perpendicular diameters) to assess response to neoadjuvant therapy. The RECIST (Response Evaluation Criteria in Solid Tumors) from the NCI will be used for assessment of the size of measurable metastases, including nodal metastases. Primary Tumor Measurement: Technical guidelines for cross-sectional imaging computed tomography (CT) slice thickness should be 5mm or less and the diameter of the "measurable" mass should be at least twice the reconstructed slice thickness. Smaller masses are considered detectable, but will be counted as "non-measurable." Complete Response (CR): Complete disappearance of the tumor confirmed at >4 weeks. Partial Response (PR): At least 64% decrease in volume compared to the measurement obtained at study enrollment. Progressive Disease (PD): At least 40% increase in tumor volume compared to the smallest volume obtained since the beginning.
Time Frame
Protocol week 6 evaluation
Title
Percentage of Patients Experiencing Adverse Events Due to Concurrent Therapy
Description
Adverse events are reported for patients receiving concurrent irinotecan hydrochloride and radiotherapy.
Time Frame
From enrollment to up to 2 years
Secondary Outcome Measure Information:
Title
Percentage of Patients Event Free at 4 Years Following Study Entry
Description
Event-free survival: Time to recurrence, second malignancy, or death as a first event, estimated from a Kaplan Meier curve
Time Frame
4 years
10. Eligibility
Sex
All
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed high-risk rhabdomyosarcoma or ectomesenchymoma
Prior enrollment on COG-D9902 to confirm local histological diagnosis required
Tissue must be submitted for pathologic review within 2 days of patient registration on COG-D9902
Newly diagnosed disease
Metastatic disease (stage IV, clinical group IV)
Has undergone initial surgical procedure (including biopsy) that provided the definitive diagnosis within the past 42 days
Parameningeal and paraspinal tumors allowed
Patients with parameningeal (without intracranial extension [ICE]) and paraspinal tumors should begin study chemotherapy at week 1 and radiotherapy at week 20
Patients with evidence of ICE, as defined by contrast MRI showing that primary tumor touches, displaces, invades, distorts, or otherwise causes a signal abnormality of the dura in contiguity to the primary site in brain or spinal cord, are eligible
ICE is presumed to exist if the cerebrospinal fluid cytopathology is positive for tumor at diagnosis
Patients requiring emergency radiotherapy are eligible
Patients requiring emergency radiotherapy (for intracranial extension or spinal cord impingement) should begin study chemotherapy at week 1 (irinotecan hydrochloride and vincristine) concurrently with radiation therapy
PATIENT CHARACTERISTICS:
ECOG or Zubrod performance status (PS) 0-2 (Lansky PS 50-100% for patients < 10 years of age and Karnofsky PS 50-100% for patients ≥ 10 years of age)
Absolute neutrophil count ≥ 750/mm³*
Platelet count ≥ 75,000/mm³*
Creatinine clearance or radioisotope glomerular filtration rate ≥ 70 mL/min (≥ 40 mL/min for infants < 1 year 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
SGPT < 2.5 times normal
Bilirubin < 1.5 mg/dL
Shortening fraction ≥ 27% by echocardiogram OR ejection fraction ≥ 50% by MUGA
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception during study and for ≥ 1 month after study completion
No evidence of uncontrolled infection
Able to undergo radiotherapy NOTE: *Abnormal blood counts allowed if there is bone marrow biopsy or aspirate proven bone marrow involvement by rhabdomyosarcoma
PRIOR CONCURRENT THERAPY:
No prior chemotherapy except steroids
No prior radiotherapy
No concurrent aprepitant during ifosfamide or doxorubicin hydrochloride chemotherapy
No concurrent dexrazoxane
No concurrent sargramostim (GM-CSF) or pegfilgrastim
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brenda Weigel, MD
Organizational Affiliation
Masonic Cancer Center, University of Minnesota
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Carola A Arndt, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Phoenix Children's Hospital
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016-7710
Country
United States
Facility Name
Arizona Cancer Center at University of Arizona Health Sciences Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-5024
Country
United States
Facility Name
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Southern California Permanente Medical Group
City
Downey
State/Province
California
ZIP/Postal Code
90242-2814
Country
United States
Facility Name
Loma Linda University Cancer Institute at Loma Linda University Medical Center
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Jonathan Jaques Children's Cancer Center at Miller Children's Hospital
City
Long Beach
State/Province
California
ZIP/Postal Code
90801
Country
United States
Facility Name
Childrens Hospital Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Facility Name
Children's Hospital Central California
City
Madera
State/Province
California
ZIP/Postal Code
93638-8762
Country
United States
Facility Name
Children's Hospital and Research Center Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94609
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
Sutter Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95816
Country
United States
Facility Name
University of California Davis Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Kaiser Permanente Medical Center - Oakland
City
Sacramento
State/Province
California
ZIP/Postal Code
95825
Country
United States
Facility Name
Rady Children's Hospital - San Diego
City
San Diego
State/Province
California
ZIP/Postal Code
92123-4282
Country
United States
Facility Name
UCSF Helen Diller Family Comprehensive Cancer Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Stanford Cancer Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5824
Country
United States
Facility Name
Children's Hospital Center for Cancer and Blood Disorders
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Carole and Ray Neag Comprehensive Cancer Center at the University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06360-2875
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
Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
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
20010-2970
Country
United States
Facility Name
Walter Reed Army Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20307-5001
Country
United States
Facility Name
Broward General Medical Center Cancer Center
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33316
Country
United States
Facility Name
Lee Cancer Care of Lee Memorial Health System
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
University of Florida Shands Cancer Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-0232
Country
United States
Facility Name
Memorial Cancer Institute at Memorial Regional Hospital
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Nemours Children's Clinic
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Miami Children's Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Baptist-South Miami Regional Cancer Program
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
Florida Hospital Cancer Institute at Florida Hospital Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803-1273
Country
United States
Facility Name
M.D. Anderson Cancer Center at Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Nemours Children's Clinic - Orlando
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Sacred Heart Cancer Center at Sacred Heart Hospital
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
St. Joseph's Cancer Institute at St. Joseph's Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Kaplan Cancer Center at St. Mary's Medical Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Winship Cancer Institute of Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
MBCCOP - Medical College of Georgia Cancer Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912-3730
Country
United States
Facility Name
Curtis and Elizabeth Anderson Cancer Institute at Memorial Health University Medical Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31403-3089
Country
United States
Facility Name
Cancer Research Center of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
University of Illinois Cancer Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-7243
Country
United States
Facility Name
Children's Memorial Hospital - Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60614
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Advocate Christ Medical Center
City
Oak Lawn
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Facility Name
Advocate Lutheran General Cancer Care Center
City
Park Ridge
State/Province
Illinois
ZIP/Postal Code
60068-1174
Country
United States
Facility Name
Saint Jude Midwest Affiliate
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61637
Country
United States
Facility Name
Simmons Cooper Cancer Institute
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62794-9677
Country
United States
Facility Name
Indiana University Melvin and Bren Simon Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202-5289
Country
United States
Facility Name
St. Vincent Indianapolis Hospital
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46260
Country
United States
Facility Name
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160-7357
Country
United States
Facility Name
Lucille P. Markey Cancer Center at University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536-0093
Country
United States
Facility Name
Kosair Children's Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40232
Country
United States
Facility Name
Tulane Cancer Center Office of Clinical Research
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71315-3198
Country
United States
Facility Name
Children's Hospital of New Orleans
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70118
Country
United States
Facility Name
Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21231-2410
Country
United States
Facility Name
Floating Hospital for Children at Tufts - New England Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
C.S. Mott Children's Hospital at University of Michigan Medical Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-0286
Country
United States
Facility Name
Barbara Ann Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201-1379
Country
United States
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48503
Country
United States
Facility Name
Butterworth Hospital at Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503-2560
Country
United States
Facility Name
CCOP - Kalamazoo
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007-5341
Country
United States
Facility Name
Breslin Cancer Center at Ingham Regional Medical 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 Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic Cancer Center
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
University of Mississippi Cancer Clinic
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216-4505
Country
United States
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Siteman Cancer Center at Barnes-Jewish St. Peters Hospital - Saint Louis
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Children's Hospital
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114-4113
Country
United States
Facility Name
UNMC Eppley Cancer Center at the University of Nebraska Medical Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68198-6805
Country
United States
Facility Name
Sunrise Hospital and Medical Center
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89109-2306
Country
United States
Facility Name
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756-0002
Country
United States
Facility Name
Hackensack University Medical Center Cancer Center
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Overlook Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
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
St. Joseph's Hospital and 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
87131-5636
Country
United States
Facility Name
Albany Medical Center Hospital
City
Albany
State/Province
New York
ZIP/Postal Code
12208-3419
Country
United States
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263-0001
Country
United States
Facility Name
Schneider Children's Hospital
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
NYU Cancer Institute at New York University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Herbert Irving Comprehensive Cancer Center at Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
James P. Wilmot Cancer Center at University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Stony Brook University Cancer Center
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794-9446
Country
United States
Facility Name
SUNY Upstate Medical University Hospital
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 - Memorial Campus
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States
Facility Name
Blumenthal Cancer Center at Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28232-2861
Country
United States
Facility Name
Presbyterian Cancer Center at Presbyterian Hospital
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28233-3549
Country
United States
Facility Name
Duke Comprehensive Cancer Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Wake Forest University Comprehensive Cancer Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157-1096
Country
United States
Facility Name
Akron Children's Hospital
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308-1062
Country
United States
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229-3039
Country
United States
Facility Name
Rainbow Babies and Children's Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106-5000
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
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
43205-2696
Country
United States
Facility Name
Children's Medical Center - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45404-1815
Country
United States
Facility Name
Toledo Hospital
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43606
Country
United States
Facility Name
Medical University of Ohio Cancer Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43614
Country
United States
Facility Name
Oklahoma University Cancer Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Oregon Health and Science University Cancer Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239-3098
Country
United States
Facility Name
Lehigh Valley Hospital - Muhlenberg
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18107
Country
United States
Facility Name
Geisinger Cancer Institute at Geisinger Health
City
Danville
State/Province
Pennsylvania
ZIP/Postal Code
17822-0001
Country
United States
Facility Name
Penn State Cancer Institute at Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033-0850
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-9786
Country
United States
Facility Name
Children's Hospital of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Hollings Cancer Center at Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Palmetto Health South Carolina Cancer Center
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Greenville Hospital Cancer Center
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Sanford Cancer Center at Sanford USD Medical Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57117-5039
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 Children's Hospital
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37901
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
37232-6838
Country
United States
Facility Name
Texas Tech University Health Sciences Center School of Medicine - 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
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Cook Children's Medical Center - Fort Worth
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Baylor University Medical Center - Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-2399
Country
United States
Facility Name
M. D. Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
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
78207
Country
United States
Facility Name
Methodist Children's Hospital of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229-3993
Country
United States
Facility Name
CCOP - Scott and White 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
84113-1100
Country
United States
Facility Name
Fletcher Allen Health Care - University Health Center Campus
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05401
Country
United States
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042-3300
Country
United States
Facility Name
Children's Hospital of The King's Daughters
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507-1971
Country
United States
Facility Name
Carilion Medical Center for Children at Roanoke Community Hospital
City
Roanoke
State/Province
Virginia
ZIP/Postal Code
24029
Country
United States
Facility Name
Children's Hospital and Regional Medical Center - Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Providence Cancer Center at Sacred Heart Medical Center
City
Spokane
State/Province
Washington
ZIP/Postal Code
99220-2555
Country
United States
Facility Name
Mary Bridge Children's Hospital and Health Center - Tacoma
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
West Virginia University Health Sciences Center - Charleston
City
Charleston
State/Province
West Virginia
ZIP/Postal Code
25302
Country
United States
Facility Name
Marshfield Clinic - Marshfield Center
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
John Hunter Hospital
City
Newcastle
State/Province
New South Wales
ZIP/Postal Code
2310
Country
Australia
Facility Name
Westmead Institute for Cancer Research at Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Facility Name
Royal Children's Hospital
City
Herston, Brisbane
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Women's and Children's Hospital
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
6001
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 1Z2
Country
Canada
Facility Name
Children's & Women's Hospital of British Columbia
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 Children's Health and Rehabilitation Centre
City
St. 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
Cancer Centre of Southeastern Ontario at Kingston General Hospital
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 3N6
Country
Canada
Facility Name
Children's Hospital of Western Ontario
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
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
Montreal Children's Hospital at McGill University Health Center
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1P3
Country
Canada
Facility Name
Hopital Sainte Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Facility Name
Saskatoon Cancer Centre at the University of Saskatchewan
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 4H4
Country
Canada
Facility Name
Centre Hospitalier Universitaire de Quebec
City
Quebec
ZIP/Postal Code
G1V 4G2
Country
Canada
Facility Name
San Jorge Children's Hospital
City
Santurce
ZIP/Postal Code
00912
Country
Puerto Rico
Facility Name
Swiss Pediatric Oncology Group Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
12. IPD Sharing Statement
Citations:
Citation
Weigel B, Lyden E, Anderson JR, et al.: Early results from Children's Oncology Group (COG) ARST0431: intensive multidrug therapy for patients with metastatic rhabdomyosarcoma (RMS). [Abstract] J Clin Oncol 28 (Suppl 15): A-9503, 2010.
Results Reference
result
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
High-Dose Combination Chemotherapy and Radiation Therapy in Treating Patients With Newly Diagnosed Metastatic Rhabdomyosarcoma or Ectomesenchymoma
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