Pre- and Post-Operative Chemotherapy With Oxaliplatin 5FU/LV Versus Surgery Alone in Resectable Liver Metastases From Colorectal Origin - Phase III Study
- Compare the progression-free and overall survival of patients with resectable
colorectal liver metastases treated with surgery with or without neoadjuvant and
adjuvant oxaliplatin, fluorouracil, and leucovorin calcium.
- Compare the percentage of patients with total resection with these two treatments.
OUTLINE: This is a multicenter study. Patients are stratified according to participating
center, prior adjuvant chemotherapy (yes vs no), plasma CEA level in ng/mL at diagnosis of
liver metastases (5 or less vs 6 to 30 vs 31 or greater), serosa extension of primary cancer
(absent T1 or T2 vs present T3 or T4), lymphatic spread of primary cancer (absent vs present
N+), time interval between diagnosis of primary tumor to metastases (2 years or more vs
fewer than 2 years), and number of metastases (1 to 3 vs 4). Patients are randomized to one
of two treatment arms.
- Arm I: Patients receive oxaliplatin IV over 2 hours on day 1 and leucovorin calcium
(LV) IV over 2 hours followed by fluorouracil (5-FU) IV over 22 hours on days 1 and 2.
Treatment repeats every 15 days for 6 courses in the absence of disease progression or
At 2 to 5 weeks after chemotherapy, patients undergo liver resection. Patients with
progressive disease after 3 courses of chemotherapy undergo liver resection at least 2 weeks
after completion of course 3 and do not receive postoperative chemotherapy.
At 2 to 5 weeks after surgery, patients receive oxaliplatin, LV, and 5-FU as in preoperative
- Arm II: Patients undergo liver resection. Patients are followed every 3 months for 2
years and then every 6 months thereafter.
Peer Reviewed and Funded or Endorsed by Cancer Research UK
PROJECTED ACCRUAL: A total of 330 patients (165 per arm) will be accrued for this study
within 3 years.
Primary Purpose: Treatment
Bernard Nordlinger, MD
Hopital Ambroise Pare
United States: Federal Government