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

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

Brief 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)


Condition or disease Intervention/treatment Phase
Colonic Neoplasms Drug: Oxaliplatin (SR96669) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2246 participants
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
Study Start Date : October 1998
Actual Primary Completion Date : April 2003
Actual Study Completion Date : April 2003

Resource links provided by the National Library of Medicine

Drug Information available for: Oxaliplatin




Primary Outcome Measures :
  1. To to detect occurrence of relapse the following examinations have to be performed for 5 years:
  2. Every 6 months for ultrasound or abdominopelvic CT scan and CEA determination,
  3. Every year for chest X-ray and colonoscopy for non polyp free patient,
  4. Every 3 years colonoscopy for polyp free patient

Secondary Outcome Measures :
  1. 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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

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


Locations
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Australia, New South Wales
sanofi-aventis Australia & New Zealand administrative office
Macquarie Park, New South Wales, Australia
Austria
Sanofi-Aventis Administrative Office
Wien, Austria
Belgium
Sanofi-Aventis Administrative Office
Diegem, Belgium
Denmark
Sanofi-Aventis Administrative Office
Horsholm, Denmark
France
Sanofi-Aventis Administrative Office
Paris, France
Germany
Sanofi-Aventis Administrative Office
Berlin, Germany
Greece
Sanofi-Aventis Administrative Office
Athens, Greece
Hungary
Sanofi-Aventis Administrative Office
Budapest, Hungary
Israel
Sanofi-Aventis Administrative Office
Natanya, Israel
Italy
Sanofi-Aventis Administrative Office
Milano, Italy
Netherlands
Sanofi-Aventis Administrative Office
Gouda, Netherlands
Norway
Sanofi-Aventis Administrative Office
Lysaker, Norway
Poland
Sanofi-Aventis Administrative Office
Warszawa, Poland
Portugal
Sanofi-Aventis Administrative Office
Porto Salvo, Portugal
Singapore
Sanofi-Aventis Administrative Office
Singapore, Singapore
Spain
Sanofi-Aventis Administrative Office
Barcelona, Spain
Sweden
Sanofi-Aventis Administrative Office
Bromma, Sweden
Switzerland
Sanofi-Aventis Administrative Office
Geneva, Switzerland
United Kingdom
Sanofi-Aventis Administrative Office
Guildford Surrey, United Kingdom
Sponsors and Collaborators
Sanofi
Investigators
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Study Chair: Aimery de Gramont, MD Hopital saint-Antoine, Oncology department
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00275210    
Other Study ID Numbers: EFC3313
First Posted: January 11, 2006    Key Record Dates
Last Update Posted: April 20, 2009
Last Verified: April 2009
Keywords provided by Sanofi:
Oxaliplatin
Chemotherapy,adjuvant
Colonic Neoplasms
Additional relevant MeSH terms:
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Colonic Neoplasms
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Oxaliplatin
Antineoplastic Agents