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

Sponsored by:	Institut Gustave Roussy
Information provided by:	Institut Gustave Roussy
ClinicalTrials.gov Identifier:	NCT00180908

Purpose

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.

Condition	Intervention	Phase
Osteosarcoma Localised High Grade Osteosarcoma of the Limbs	Drug: Etoposide, Ifosfamide, Methotrexate Drug: Doxorubicin, Methotrexate	Phase III

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Ifosfamide Etoposide Methotrexate Etoposide phosphate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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

Further study details as provided by Institut Gustave Roussy:

Primary Outcome Measures:

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

Secondary Outcome Measures:

Event-free survival,
Overall survival,
Toxicity.

Estimated Enrollment:	226
Study Start Date:	June 1994

Eligibility

Ages Eligible for Study:	up to 20 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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,

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00180908

Locations

France
Institut Gustave-Roussy
Villejuif, France, 94805

Sponsors and Collaborators

Institut Gustave Roussy

Investigators

Study Chair:

Chantal Kalifa, MD

Institut Gustave Roussy

More Information

Publications indexed to this study:

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. Epub 2007 Jan 30.

Study ID Numbers:	OS94, CSET-94-300
Study First Received:	September 12, 2005
Last Updated:	September 12, 2005
ClinicalTrials.gov Identifier:	NCT00180908
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by Institut Gustave Roussy:

Osteosarcoma

Study placed in the following topic categories:

Malignant mesenchymal tumor
Osteosarcoma
Osteogenic sarcoma
Etoposide phosphate
Soft tissue sarcomas
Doxorubicin
Folic Acid

Neoplasms, Connective and Soft Tissue
Ifosfamide
Mechlorethamine
Sarcoma
Methotrexate
Etoposide
Isophosphamide mustard

Additional relevant MeSH terms:

Antimetabolites
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Reproductive Control Agents
Antibiotics, Antineoplastic
Therapeutic Uses
Abortifacient Agents
Alkylating Agents
Dermatologic Agents
Nucleic Acid Synthesis Inhibitors

Neoplasms by Histologic Type
Enzyme Inhibitors
Abortifacient Agents, Nonsteroidal
Folic Acid Antagonists
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms, Bone Tissue
Antineoplastic Agents, Alkylating
Neoplasms, Connective Tissue
Antirheumatic Agents
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on January 16, 2009