Ifosfamide and Doxorubicin, Radiation Therapy, and/or Surgery in Treating Young Patients With Localized Soft Tissue Sarcoma

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

Summary

RATIONALE: 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 more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy with or without radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery.

PURPOSE: This phase III trial is studying how well giving ifosfamide and doxorubicin, radiation therapy, and/or surgery works in treating young patients with localized soft tissue sarcoma.

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

Details

• Lead Sponsor: European Paediatric Soft Tissue Sarcoma Study Group
• Collaborators: Children's Cancer and Leukaemia Group; Cooperative Weichteilsarkom Studie; Dutch Childhood Oncology Group; Italian Association for Pediatric Hematology Oncology
• Treatments: Doxorubicin; Ifosfamide; Isophosphamide mustard; Liposomal doxorubicin

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed synovial sarcoma or adult-type soft-tissue sarcoma

• Adult-type soft tissue sarcoma includes any of the following:

• Fibrosarcoma (adult-type)

• No infantile fibrosarcoma

• Malignant peripheral nerve sheath tumor

• Malignant schwannoma

• Neurofibrosarcoma

• Epithelioid sarcoma

• Leiomyosarcoma

• Clear cell sarcoma

• Liposarcoma

• Alveolar soft-part sarcoma

• Malignant fibrous histiocytoma

• Hemangiopericytoma

• Angiosarcoma

• Dermatofibrosarcoma protuberans

• Mesenchymal chondrosarcoma

• No borderline tumors (e.g., hemangioendothelioma)

• No small round cell tumors (e.g., extraosseous Ewing's sarcoma/primitive neuroectodermal tumor or desmoplastic small round cell tumor)

• Post-irradiation soft-part sarcomas allowed

• Diagnostic surgery performed within the past 8 weeks (for patients who require adjuvant chemotherapy)

• No evidence of metastatic disease

• Involved locoregional lymph nodes are allowed

PATIENT CHARACTERISTICS:

• No prior malignancy

• No pre-existing illness precluding study treatment*

• Normal renal function (nephrotoxicity grade 0-1)*

• No history of cardiac disease*

• Normal shortening fraction (> 28%)*

• Ejection fraction > 47%* NOTE: * For patients who require adjuvant chemotherapy

PRIOR CONCURRENT THERAPY:

• No prior cancer treatment except primary surgery