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

Sponsor
Gustave Roussy, Cancer Campus, Grand Paris (Other)
Overall Status
Completed
CT.gov ID
NCT00180908
Collaborator
(none)
226
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Etoposide, Ifosfamide, Methotrexate
  • Drug: Doxorubicin, Methotrexate
Phase 3

Study Design

Study Type:
Interventional
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Study Start Date :
Jun 1, 1994

Outcome Measures

Primary Outcome Measures

  1. Good histological response (5% or less viable cells) after preoperative chemotherapy []

Secondary Outcome Measures

  1. Event-free survival, []

  2. Overall survival, []

  3. Toxicity. []

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A to 20 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Institut Gustave-Roussy Villejuif France 94805

Sponsors and Collaborators

  • Gustave Roussy, Cancer Campus, Grand Paris

Investigators

  • Study Chair: Chantal Kalifa, MD, Gustave Roussy, Cancer Campus, Grand Paris

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT00180908
Other Study ID Numbers:
  • OS94
  • CSET-94-300
First Posted:
Sep 16, 2005
Last Update Posted:
Sep 16, 2005
Last Verified:
Sep 1, 2005
Keywords provided by , ,
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 16, 2005