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


Phase 3
18 Years
75 Years
Not Enrolling
Both
Colonic Neoplasms

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Trial Information

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

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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

Principal Investigator

Aimery de Gramont, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Hopital saint-Antoine, Oncology department

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

EFC3313

NCT ID:

NCT00275210

Start Date:

October 1998

Completion Date:

April 2003

Related Keywords:

  • Colonic Neoplasms
  • Oxaliplatin
  • Chemotherapy,adjuvant
  • Colonic Neoplasms
  • Neoplasms
  • Colonic Neoplasms

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