The percentage of patients with defined unresectable metastatic disease who will benefit from
a first-line treatment enabling secondary complete metastasectomy is unknown but limited.
Definition of optimized treatment algorithms is difficult due to very inhomogeneous patient
populations.
This open label, multicentre Phase II study primarily aims to assess the resection rate
achievable in a selected patient population with initially unresectable metastatic disease
limited to the liver only in order to evaluate feasibility, safety and efficacy with regards
to secondary resection of hepatic lesions in these patients.
The trial aims to enrol only patients meeting defined criteria of unresectability with
regards to their hepatic lesions and will exclude patients with extrahepatic lesions in order
to examine the most appropriate, highly active treatment regimen for this group of
unresectable patients with the highest probability of a successful secondary metastasectomy
with curative intent. The trial will be conducted in highly specialized centres with a track
record of successful interdisciplinary treatment approaches in the field of metastatic
colorectal cancer to allow the precise assessment of the peri-operative safety parameters as
well as an evaluation of the surgical treatment approaches.
The IXO regimen selected for this study has shown in a phase I/II study promising efficacy
and a favourable safety profile. Bevacizumab has demonstrated a significant survival benefit
in combination with chemotherapy in metastatic colorectal cancer. Therefore the study will
allow evaluation of its potential benefit in combination with the two most active current
chemotherapy regimens in the first-line and post-operative treatment setting.