Clinical trial · Interventional
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
NCT00180908CI-TRIAL-00000160completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Localised High Grade Osteosarcoma of the Limbs | — | UNRESOLVED | — |
| Osteosarcoma | Osteosarcoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Doxorubicin, Methotrexate | Drug | — | UNRESOLVED |
| Etoposide, Ifosfamide, Methotrexate | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Good histological response (5% or less viable cells) after preoperative chemotherapy
Secondary outcomes (3)
- measure
- Event-free survival,
- measure
- Overall survival,
- measure
- Toxicity.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 20 Years
Show eligibility criteria text
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,
References
Publications (2)
- DERIVEDHattinger CM, Patrizio MP, Magagnoli F, Luppi S, Serra M. An update on emerging drugs in osteosarcoma: towards tailored therapies? Expert Opin Emerg Drugs. 2019 Sep;24(3):153-171. doi: 10.1080/14728214.2019.1654455. Epub 2019 Aug 14. PMID 31401903
- DERIVEDLe Deley MC, Guinebretiere JM, Gentet JC, Pacquement H, Pichon F, Marec-Berard P, Entz-Werle N, Schmitt C, Brugieres L, Vanel D, Dupouy N, Tabone MD, Kalifa C; Societe Francaise d'Oncologie Pediatrique (SFOP). SFOP OS94: a randomised trial comparing preoperative high-dose methotrexate plus doxorubicin to high-dose methotrexate plus etoposide and ifosfamide in osteosarcoma patients. Eur J Cancer. 2007 Mar;43(4):752-61. doi: 10.1016/j.ejca.2006.10.023. Epub 2007 Jan 30. PMID 17267204