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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00180908

Enrollment

226

Registered

2005-09-16

Start date

1994-06-30

Completion date

Unknown

Last updated

2005-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Localised High Grade Osteosarcoma of the Limbs, Osteosarcoma

Keywords

Osteosarcoma

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.

Interventions

DRUGEtoposide, Ifosfamide, Methotrexate

DRUGDoxorubicin, Methotrexate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 20 Years

Healthy volunteers

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,

Design outcomes

Primary

Measure	Time frame
Good histological response (5% or less viable cells) after preoperative chemotherapy	—

Secondary

Measure	Time frame
Event-free survival,	—
Overall survival,	—
Toxicity.	—

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026