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

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Leicester
• Collaborators: Children's Cancer and Leukaemia Group; Children's Oncology Group; EBMT Solid Tumors Working Party; European Organisation for Research and Treatment of Cancer - EORTC; Gesellschaft fur Padiatrische Onkologie und Hamatologie - Austria; National Cancer Institute (NCI); Societe Francaise Oncologie Pediatrique; Swiss Group for Clinical Cancer Research
• Treatments: Busulfan; Dactinomycin; Doxorubicin; Etoposide; Ifosfamide; Isophosphamide mustard; Liposomal doxorubicin; Melphalan; Vincristine

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed tumor of the Ewing's family of bone or soft tissue

• Ewing's sarcoma

• Peripheral primitive neuroectodermal tumor

• Disease meeting one of the following criteria:

• Resectable localized disease (tumor volume less than 200 mL)

• Localized disease previously resected at diagnosis

• Unresectable disease (at least 200 mL tumor volume) but radiotherapy as local control can be delayed

• Localized disease with early radiotherapy required

• Pulmonary and/or pleural metastases only

• Extrapulmonary/pleural metastases (skeleton, bone marrow, lymph nodes)

• No more than 45 days since definitive biopsy

PATIENT CHARACTERISTICS:

Age:

• Under 50

Performance status:

• Not specified

Life expectancy:

• Not specified

Hematopoietic:

• Not specified

Hepatic:

• Not specified

Renal:

• Renal function normal

• Glomerular filtration rate at least 60 mL/min

Cardiovascular:

• Normal cardiac function

• Fractional shortening at least 29%

• Ejection fraction at least 40%

Other:

• No medical, psychiatric, or social condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• No prior chemotherapy

Endocrine therapy:

• Not specified

Radiotherapy:

• Not specified

Surgery:

• See Disease Characteristics