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MOSAIC - Multicenter International Study of Oxaliplatin/ 5FU-LV in the Adjuvant Treatment of Colon Cancer

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ClinicalTrials.gov Identifier: NCT00275210
Recruitment Status : Completed
First Posted : January 11, 2006
Last Update Posted : April 20, 2009
Sponsor:
Information provided by:
Sanofi

January 3, 2006
January 11, 2006
April 20, 2009
October 1998
April 2003   (Final data collection date for primary outcome measure)
  • To to detect occurrence of relapse the following examinations have to be performed for 5 years:
  • Every 6 months for ultrasound or abdominopelvic CT scan and CEA determination,
  • Every year for chest X-ray and colonoscopy for non polyp free patient,
  • Every 3 years colonoscopy for polyp free patient
  • To to detect occurrence of relapse the following examinations have to be performed for 5 years:
  • - Every 6 months for ultrasound or abdominopelvic CT scan and CEA determination,
  • - Every year for chest X-ray and colonoscopy for non polyp free patient,
  • - Every 3 years colonoscopy for polyp free patient
Complete list of historical versions of study NCT00275210 on ClinicalTrials.gov Archive Site
Every 2 weeks clinical and laboratory tests (hematological, creatinine and liver tests) for safety evaluation during treatment then every 6 months neurological examination Date of death for OS
Same as current
Not Provided
Not Provided
 
MOSAIC - Multicenter International Study of Oxaliplatin/ 5FU-LV in the Adjuvant Treatment of Colon Cancer
Multicenter International Study of Oxaliplatin/ 5FU-LV in the Adjuvant Treatment of Colon Cancer

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)

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Colonic Neoplasms
Drug: Oxaliplatin (SR96669)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2246
2200
April 2003
April 2003   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 75 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Austria,   Belgium,   Denmark,   France,   Germany,   Greece,   Hungary,   Israel,   Italy,   Netherlands,   Norway,   Poland,   Portugal,   Singapore,   Spain,   Sweden,   Switzerland,   United Kingdom
 
 
NCT00275210
EFC3313
Not Provided
Not Provided
Not Provided
ICD Study Director, sanofi-aventis
Sanofi
Not Provided
Study Chair: Aimery de Gramont, MD Hopital saint-Antoine, Oncology department
Sanofi
April 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP