Clinical trial

Fluorouracil and Irinotecan With or Without Leucovorin Compared With Observation…

NCT00091312 · Federation Francophone de Cancerologie Digestive, Other · Unknown status

Key facts

NCT number NCT00091312
Title Fluorouracil and Irinotecan With or Without Leucovorin Compared With Observation in Treating Patients Who Have Undergone Surgery for Stage II Colon Cancer
Official title Randomized Phase III Intergroup Trial in Resected Stage 2 (Dukes B) Colon Cancer: 6-Month Infusional 5FU-CPT11 (+/- Folinic Acid) Versus Observation - Determination of Biologic Predictive and Response Factors
Lead sponsor Federation Francophone de Cancerologie Digestive, Other
Status Unknown status
Phase Phase 3
Study type Interventional
Conditions Colorectal Cancer
Intervention type Drug, Procedure
Interventions FOLFIRI regimen, fluorouracil, irinotecan hydrochloride, leucovorin calcium, adjuvant therapy
Enrollment 1,976
Start date Jun 1, 2004
First posted Sep 9, 2004
Last update posted Feb 9, 2009
Countries Egypt, France, Germany, Italy, Portugal, Spain

At a glance

  • 1–9 Study sites
  • No Results posted
  • None Linked FDA submissions

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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