Last updated on June 2014

Combination Chemotherapy With or Without Peripheral Stem Cell Transplantation Radiation Therapy and/or Surgery in Treating Patients With Ewing's Sarcoma


Brief description of study

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy and kill more tumor cells. It is not yet known if combination chemotherapy is more effective with or without radiation therapy and/or surgery in treating Ewing's sarcoma. PURPOSE: This randomized phase III trial is studying different combination chemotherapy regimens to see how well they work when given with or without peripheral stem cell transplantation, radiation therapy, and/or surgery in treating patients with Ewing's sarcoma.

Detailed Study Description

OBJECTIVES: Primary - Compare the event-free and overall survival of patients with tumor of the Ewing's family treated with standard induction chemotherapy comprising vincristine, dactinomycin, ifosfamide and etoposide (VIDE) followed by consolidation chemotherapy comprising vincristine, dactinomycin, and ifosfamide versus high-dose busulfan and melphalan (Bu-Mel) followed by autologous peripheral blood stem cell (PBSC) transplantation with or without radiotherapy and/or surgery. Secondary - Determine the prognostic significance of EWS-Flil transcript in these patients. - Determine the frequency and prognostic value of minimal disease in bone marrow and PBSC, as determined by the presence or absence of EWS-Flil transcript, in these patients. - Determine the feasibility and toxicity of VIDE induction chemotherapy in these patients. - Determine the response of these patients to VIDE induction chemotherapy. - Determine the feasibility and toxicity of VAI consolodation chemotherapy in these patients. - Determine the feasibility and toxicity of Bu-Mel consolodation chemotherapy in these patients. - Determine event-free survival and overall survival of patients treated with these regimens by prognostic group analysis. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age and local treatment of the primary tumor (yes vs no). Patients receive induction chemotherapy comprising vincristine IV on day 1 and ifosfamide IV over 3 hours, doxorubicin IV over 4 hours, and etoposide IV over 1 hour on days 1-3 (VIDE). Treatment repeats every 21 days for 4 courses in the absence of unacceptable toxicity. Peripheral blood stem cells (PBSC) are collected after course 3 and/or 4. Patients are evaluated after course 4. Patients in need of early radiotherapy due to an axial tumor or patients who require radiotherapy to the brain and/or spinal cord (at any time during study) are assigned to group 1. Patients not needing early radiotherapy are assigned to group 2. - Group 1: Patients receive 2 additional courses of VIDE induction chemotherapy (courses 5 and 6). Patients requiring radiotherapy to the axial tumor also undergo concurrent radiotherapy 5 days a week. Some patients may then undergo surgical resection of the tumor. All patients will then receive vincristine IV on day 1 and dactinomycin IV and ifosfamide IV over 3 hours on days 1 and 2 (VAI). Treatment repeats every 21 days for 8 courses (courses 7-14). Patients requiring radiotherapy to the brain and/or spinal cord also undergo concurrent radiotherapy. - Group 2: Patients undergo 2 additional courses of VIDE induction chemotherapy (courses 5 and 6). Some patients may then undergo surgical resection of the tumor. All patients receive VAI chemotherapy as in group 1 for 1 course. Patients are randomized to 1 of 2 consolidation therapy arms. - Arm I: Patients receive 7 additional courses of VAI chemotherapy (courses 8-14). Patients with unresectable, partially resected, or inadequately resected disease undergo concurrent whole-lung radiotherapy for 6-12 days. - Arm II: Patients receive high-dose chemotherapy comprising oral busulfan every 6 hours on days -6 to -3 and melphalan IV over 30 minutes on day -2. Patients receive autologous PBSC IV on day 0. Patients with unresectable, partially resected, or inadequately resected disease undergo concurrent radiotherapy 5 days a week for at least 5 weeks. Patients are followed every 3 months for 4 years, every 6 months for 1 year, and then periodically thereafter. Peer Reviewed and Funded or Endorsed by Cancer Research UK PROJECTED ACCRUAL: Approximately 1,200 patients will be accrued for this study within approximately 7 years.

Clinical Study Identifier: NCT00020566

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Phoenix Children's Hospital
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Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
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City of Hope Comprehensive Cancer Center
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Childrens Hospital Los Angeles
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Southern California Permanente Medical Group
Los Angeles, CA United States
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Neyssa M. Marina

Lucile Packard Children's Hospital at Stanford University Medical Center
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Kaiser Permanente Medical Center - Oakland
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Children's Hospital Colorado Center for Cancer and Blood Disorders
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Alfred I. duPont Hospital for Children
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Children's National Medical Center
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Nemours Children's Clinic
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Nemours Children's Clinic - Orlando
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Nemours Children's Clinic - Pensacola
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All Children's Hospital
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St. Joseph's Cancer Institute at St. Joseph's Hospital
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Kaplan Cancer Center at St. Mary's Medical Center
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AFLAC Cancer Center and Blood Disorders Service of Children's Healthcare of Atlanta - Egleston Campus
Atlanta, GA United States
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Cancer Research Center of Hawaii
Honolulu, HI United States
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Mountain States Tumor Institute at St. Luke's Regional Medical Center
Boise, ID United States
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University of Chicago Cancer Research Center
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Saint Jude Midwest Affiliate
Peoria, IL United States
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Simmons Cooper Cancer Institute
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Holden Comprehensive Cancer Center at University of Iowa
Iowa City, IA United States
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Kosair Children's Hospital
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Children's Hospital of New Orleans
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Alvin and Lois Lapidus Cancer Institute at Sinai Hospital
Baltimore, MD United States
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Dana-Farber/Harvard Cancer Center at Dana-Farber Cancer Institute
Boston, MA United States
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Hurley Medical Center
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Helen DeVos Children's Hospital at Spectrum Health
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Van Elslander Cancer Center at St. John Hospital and Medical Center
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Bronson Methodist Hospital
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Masonic Cancer Center at University of Minnesota
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Mayo Clinic Cancer Center
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Children's Hospitals and Clinics of Minnesota - St. Paul
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University of Mississippi Cancer Clinic
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Children's Mercy Hospital
Kansas City, MO United States
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Siteman Cancer Center at Barnes-Jewish Hospital - Saint Louis
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CCOP - Nevada Cancer Research Foundation
Las Vegas, NV United States
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Roswell Park Cancer Institute
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James P. Wilmot Cancer Center at University of Rochester Medical Center
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Cleveland Clinic Taussig Cancer Center
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Rainbow Babies and Children's Hospital
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Nationwide Children's Hospital
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Dayton Children's - Dayton
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Oklahoma University Cancer Institute
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Lehigh Valley Hospital - Muhlenberg
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Penn State Children's Hospital
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Children's Hospital of Philadelphia
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Avera Cancer Institute
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East Tennessee Children's Hospital
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Texas Tech University Health Sciences Center School of Medicine - Amarillo
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Primary Children's Medical Center
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Children's Hospital of The King's Daughters
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Midwest Children's Cancer Center at Children's Hospital of Wisconsin
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Children's Hospital at Westmead
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Royal Children's Hospital
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Women's and Children's Hospital
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Princess Margaret Hospital for Children
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University of Alberta Hospital
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Children's and Women's Hospital of British Columbia
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CancerCare Manitoba
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Janeway Children's Health and Rehabilitation Centre
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IWK Health Centre
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Hospital for Sick Children
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Hopital Sainte Justine
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Saskatoon Cancer Centre at the University of Saskatchewan
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Centre Hospitalier Universitaire de Quebec
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Starship Children's Health
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San Jorge Children's Hospital
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