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
- 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.
- 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
- 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
PROJECTED ACCRUAL: Approximately 1,600 patients (800 per treatment arm) will be accrued for
this study within 3 years.
Allocation: Randomized, Primary Purpose: Treatment
Claus-Henning Koehne, MD
United States: Federal Government