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Completed

NCT Number: NCT00275210

MOSAIC - 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)

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Key information

Conditions

Colonic Neoplasms Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

sanofi-aventis Australia & New Zealand administrative office, Macquarie Park, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Oxaliplatin (SR96669)

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

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

Important dates

Study start
1998
Primary completion
2003
Study completion
2003
First posted
Jan 11, 2006
Registry last updated
Apr 20, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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