Comparison of High-Dose Methotrexate (HDM) Plus Doxorubicin to HDM Plus Etoposide-Ifosfamide in Osteosarcoma Children

Osteosarcoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00180908
• Other study ID #: OS94
• Secondary ID: CSET-94-300
• Status: Completed
• Phase: Phase 3
• First received: September 12, 2005
• Last updated: September 12, 2005
• Start date: June 1994

Study information

• Verified date: September 2005
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 20 Years

Eligibility

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,

Study Design

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

Related Conditions & MeSH terms

• Localised High Grade Osteosarcoma of the Limbs
• Osteosarcoma

Intervention

Drug:
• Etoposide, Ifosfamide, Methotrexate

• Doxorubicin, Methotrexate

Locations

Country	Name	City	State
France	Institut Gustave-Roussy	Villejuif

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Good histological response (5% or less viable cells) after preoperative chemotherapy
Secondary	Event-free survival,
Secondary	Overall survival,
Secondary	Toxicity.