MOSAIC - Multicenter International Study of Oxaliplatin/ 5FU-LV in the Adjuvant Treatment of Colon Cancer
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Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase III | Treatment | Completed | 18 to 75 | Pharmaceutical / Industry | EFC3313 NCT00275210 |
Summary
To evaluate the FOLFOX regimen versus LV5FU2 in the adjuvant treatment of stage II and III colon cancer.
Primary objective: Disease Free Survival (DFS) Secondary objective: Overall Survival (OS), safety (including long term toxicity)
Eligibility Criteria
Main selection criteria:
- Histologically proven stage Dukes " B2 " (stage II: T3-T4 N0 M0) and " C " (stage III: any T N1-2 M0) colon carcinoma. The inferior pole of the tumor must be above the peritoneal reflection (> 15 cm from the anal margin)·
- Complete resection of the primary tumor without gross or microscopic evidence of residual disease
- Treatment within 7 weeks following surgery
- Age 18-75 years old
- ECOG PS £ 2
- No prior chemo, immuno or radiotherapy
Trial Lead Organizations/Sponsors
Sanofi-Aventis United Kingdom
| Aimery de Gramont |  | Study Chair |
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00275210
Information obtained from ClinicalTrials.gov on November 22, 2012
Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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