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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00275210
First Posted: January 11, 2006
Last Update Posted: April 20, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanofi
  Purpose

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)


Condition Intervention Phase
Colonic Neoplasms Drug: Oxaliplatin (SR96669) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Multicenter International Study of Oxaliplatin/ 5FU-LV in the Adjuvant Treatment of Colon Cancer

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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

Secondary Outcome Measures:
  • 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

Enrollment: 2246
Study Start Date: October 1998
Study Completion Date: April 2003
Primary Completion Date: April 2003 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00275210


  Show 19 Study Locations
Sponsors and Collaborators
Sanofi
Investigators
Study Chair: Aimery de Gramont, MD Hopital saint-Antoine, Oncology department
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00275210     History of Changes
Other Study ID Numbers: EFC3313
First Submitted: January 3, 2006
First Posted: January 11, 2006
Last Update Posted: April 20, 2009
Last Verified: April 2009

Keywords provided by Sanofi:
Oxaliplatin
Chemotherapy,adjuvant
Colonic Neoplasms

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Oxaliplatin
Antineoplastic Agents