Colorectal Cancer Clinical Trial
Official title:
Pan-European Trials in Adjuvant Colon Cancer (PETACC-2): Randomized Phase III Intergroup Trial of High-Dose Infusional 5-FU (+ or - Folinic Acid) Versus Standard Bolus 5-FU/Folinic Acid
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.
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.
;
Allocation: Randomized, Primary Purpose: Treatment
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