High-Dose Fluorouracil With or Without Leucovorin Compared With Standard Fluorouracil Plus Leucovorin Following Surgery in Treating Patients With Stage III Colon Cancer

Phase 3

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT00004150
• Lead Sponsor: Robert Roessle Klinik

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which chemotherapy regimen is more effective for colon cancer.

PURPOSE: This randomized phase III trial is studying high-dose fluorouracil with or without leucovorin to see how well it works compared to standard-dose fluorouracil and leucovorin in treating patients who have undergone surgery for stage III colon cancer.

Detailed Description

OBJECTIVES:

* Compare recurrence-free survival and duration of survival in patients with stage III adenocarcinoma of the colon treated with adjuvant high-dose fluorouracil with or without leucovorin calcium versus standard fluorouracil with leucovorin calcium following curative radical resection.

* Compare the safety of these regimens in this patient population.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to regional lymph node involvement (N1 (1-3 pericolic lymph nodes) vs N2 (more than 3 pericolic lymph nodes) and participating center.

Patients are randomized to one of two treatment arms.

* Arm I: Patients receive leucovorin calcium IV followed by fluorouracil IV on days 1-5. Treatment repeats every 4 weeks for 6 courses.

* Arm II: Patients receive high-dose fluorouracil IV continuously over 48 hours weekly for 8 weeks. Treatment repeats every 8 weeks for 3 courses.

OR

* Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV continuously over 24 hours weekly for 6 weeks. Treatment repeats every 7 weeks for 3 courses.

OR

* Patients receive leucovorin calcium IV over 2 hours followed by fluorouracil IV bolus and then fluorouracil IV continuously over 22 hours on days 1 and 2. Treatment repeats every 2 weeks for 12 courses.

Patients are followed at 1 month, every 6 months for 4.5 years, and then annually thereafter until death.

PROJECTED ACCRUAL: Approximately 1,600 patients (800 per treatment arm) will be accrued for this study within 3 years.

Study Timeline

• Study Start: 1999-03
• Study First Submitted: 1999-12-10
• Status Verified: 2001-02
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Study Completion: 2007-04
• Last Update Submitted: 2013-11-05
• Last Update Posted: 2013-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (84)

Ziekenhuis Network Antwerpen Middelheim; 🇧🇪 Antwerpen, Belgium

Institut Jules Bordet; 🇧🇪 Brussels, Belgium

Hopital Universitaire Erasme; 🇧🇪 Brussels, Belgium

Universitair Ziekenhuis Antwerpen; 🇧🇪 Edegem, Belgium

U.Z. Gasthuisberg; 🇧🇪 Leuven, Belgium

CHU Liege - Domaine Universitaire du Sart Tilman; 🇧🇪 Liege, Belgium

Centre Hospitalier Peltzer-La Tourelle; 🇧🇪 Verviers, Belgium

Centre Hospitalier Regional et Universitaire d'Angers; 🇫🇷 Angers, France

Clinique St. Etienne; 🇫🇷 Bayonne, France

Centre Hospitalier General; 🇫🇷 Brive, France

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