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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


Phase 3
N/A
20 Years
Not Enrolling
Both
Osteosarcoma, Localised High Grade Osteosarcoma of the Limbs

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Trial Information

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


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,

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Good histological response (5% or less viable cells) after preoperative chemotherapy

Principal Investigator

Chantal Kalifa, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Gustave Roussy, Cancer Campus, Grand Paris

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

OS94

NCT ID:

NCT00180908

Start Date:

June 1994

Completion Date:

Related Keywords:

  • Osteosarcoma
  • Localised High Grade Osteosarcoma of the Limbs
  • Osteosarcoma
  • Osteosarcoma

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