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

Primary Purpose

Colonic Neoplasms

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Oxaliplatin (SR96669)

About this trial

This is an interventional treatment trial for Colonic Neoplasms focused on measuring Oxaliplatin, Chemotherapy,adjuvant, Colonic Neoplasms

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Outcomes

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

Full Information

NCT ID

NCT00275210

First Posted

January 3, 2006

Last Updated

April 17, 2009

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00275210

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2009

Overall Recruitment Status

Completed

Study Start Date

October 1998 (undefined)

Primary Completion Date

April 2003 (Actual)

Study Completion Date

April 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Sanofi

4. Oversight

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colonic Neoplasms

Keywords

Oxaliplatin, Chemotherapy,adjuvant, Colonic Neoplasms

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

2246 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

Oxaliplatin (SR96669)

Primary Outcome Measure Information:

Title

To to detect occurrence of relapse the following examinations have to be performed for 5 years:

Title

Every 6 months for ultrasound or abdominopelvic CT scan and CEA determination,

Title

Every year for chest X-ray and colonoscopy for non polyp free patient,

Title

Every 3 years colonoscopy for polyp free patient

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Aimery de Gramont, MD

Organizational Affiliation

Hopital saint-Antoine, Oncology department

Official's Role

Study Chair

Facility Information:

Facility Name

sanofi-aventis Australia & New Zealand administrative office

City

Macquarie Park

State/Province

New South Wales

Country

Australia

Facility Name