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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00180908 |
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Date of registration:
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12/09/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Comparison of High-Dose Methotrexate (HDM) Plus Doxorubicin to HDM Plus Etoposide-Ifosfamide in Osteosarcoma Children
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Scientific title:
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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 |
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Date of first enrolment:
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June 1994 |
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Target sample size:
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226 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00180908 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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France
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Contacts
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Name:
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Chantal Kalifa, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Gustave Roussy, Cancer Campus, Grand Paris |
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Key inclusion & exclusion 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,
Age minimum:
N/A
Age maximum:
20 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Osteosarcoma
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Localised High Grade Osteosarcoma of the Limbs
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Intervention(s)
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Drug: Doxorubicin, Methotrexate
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Drug: Etoposide, Ifosfamide, Methotrexate
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Primary Outcome(s)
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Good histological response (5% or less viable cells) after preoperative chemotherapy
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Secondary Outcome(s)
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Overall survival,
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Toxicity.
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Event-free survival,
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Secondary ID(s)
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OS94
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CSET-94-300
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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