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 |
---|---|---|
|
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
- Good histological response (5% or less viable cells) after preoperative chemotherapy []
Secondary Outcome Measures
- Event-free survival, []
- Overall survival, []
- 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: