Status:
UNKNOWN
Ifosfamide and Doxorubicin, Radiation Therapy, and/or Surgery in Treating Young Patients With Localized Soft Tissue Sarcoma
Lead Sponsor:
European Paediatric Soft Tissue Sarcoma Study Group
Collaborating Sponsors:
Italian Association for Pediatric Hematology Oncology
Cooperative Weichteilsarkom Studie
Conditions:
Childhood Malignant Fibrous Histiocytoma of Bone
Sarcoma
Eligibility:
All Genders
Up to 20 years
Phase:
PHASE3
Brief 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. Givi...
Detailed Description
OBJECTIVES: Primary * Determine survival rates (event-free survival and overall survival \[OS\]) and the pattern of treatment failure in patients with synovial sarcoma or adult-type soft tissue sarc...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00334854
Start Date
March 1 2006
Last Update
August 12 2013
Active Locations (28)
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1
St. Anna Children's Hospital
Vienna, Austria, A-1090
2
Clinique de l'Esperance
Montegnée, Belgium, 4420
3
Rigshospitalet - Copenhagen University Hospital
Copenhagen, Denmark, 2100
4
Institut Curie Hopital
Paris, France, 75248