UnknownPhase 3

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

Austria, Belgium, Denmark250 participantsStarted 2006-03

Plain-language 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.

Who can participate

Age range20 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Event-free survival

Local relapse-free survival

Metastases-free survival

Overall survival

Response rate (complete response, very good partial response [PR], PR, minor PR, and stable disease)

Trial details

NCT IDNCT00334854

SponsorEuropean Paediatric Soft Tissue Sarcoma Study Group

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2010-05