NCT00180908CompletedPhase 3
SFOP-OS94: Multicentric Randomised Phase III Trial Comparing Efficacy of Preoperative High-Dose Methotrexate Plus Doxorubicin to Efficacy of High-Dose Methotrexate Plus Etoposide and Ifosfamide, in Children and Adolescents Osteosarcoma
Gustave Roussy, Cancer Campus, Grand Paris2 sites in 1 country226 target enrollmentStarted: June 1994Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Enrollment
- 226
- Locations
- 2
- Primary Endpoint
- Good histological response (5% or less viable cells) after preoperative chemotherapy
Study Overview
Brief Summary
The purpose of this study is to compare two preoperative chemotherapy regimens based on high-dose methotrexate courses given alternately either with doxorubicin or with etoposide-ifosfamide.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- — to 20 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •non metastatic limb osteosarcoma,
- •age less than 20 years,
- •biopsy proven high-grade osteosarcoma,
- •no previous treatment,
- •no contraindication to chemotherapy
- •no previous malignancy,
- •Written informed consent.
Exclusion Criteria
- •juxta-cortical sarcoma and microcellular anaplastic sarcoma,
- •previous anticancer treatment
- •contraindication to chemotherapy
- •previous malignancy,
Outcomes
Primary Outcomes
Good histological response (5% or less viable cells) after preoperative chemotherapy
Secondary Outcomes
- Event-free survival,
- Overall survival,
- Toxicity.
Investigators
Study Sites (2)
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