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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

226 participants

Study Classification

INTERVENTIONAL

Study Start Date

1994-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Osteosarcoma Localised High Grade Osteosarcoma of the Limbs

Keywords

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Osteosarcoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Etoposide, Ifosfamide, Methotrexate

Intervention Type DRUG

Doxorubicin, Methotrexate

Intervention Type DRUG

Eligibility Criteria

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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,

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Chantal Kalifa, MD

Role: STUDY_CHAIR

Gustave Roussy, Cancer Campus, Grand Paris

Locations

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Institut Gustave-Roussy

Villejuif, , France

Site Status

Countries

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France

References

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Hattinger 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.

Reference Type DERIVED

PMID: 31401903 (View on PubMed)

Le 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.