EORTC 40983 Trial

Trial Name:

Pre and Post-operative chemotherapy with oxaliplatin 5FU/LV V surgery alone if resectable liver metastases from colorectal origin—Phase III study

Objectives:

Is pre- and post-operative chemotherapy with oxaliplatin plus 5FU/LV of benefit compared to surgery alone for patients with resectable liver metastases from colorectal origin?

Primary: Progression Free Survival
Secondary: Overall survival, Tumor resectability, Tumor response

Design:

Randomized multicenter, Phase III Clinical Trial

Status:

Complete

Population:

• All potentially resectable liver metastases without detectable extra-hepatic tumor.
• Primary tumor resected (R0 resection) or resectable (synchronous metastases).
• No previous chemotherapy with oxaliplatin. Adjuvant chemotherapy for the primary cancer is allowed unless it contained oxaliplatin.

Publications:

Perioperative FOLFOX4 chemotherapy and surgery versus surgery alone for resectable liver metastases from colorectal cancer (EORTC 40983): long-term results of a randomised, controlled, phase 3 trial

Perioperative chemotherapy with FOLFOX4 and surgery versus surgery alone for resectable liver metastases from colorectal cancer (EORTC Intergroup trial 40983): a randomised controlled trial

Contact details:

All Trial enquiries should be addressed to ctu@soton.ac.uk