A Multicentre Randomized Phase II Study to Assess the Safety and Resectablity in Patients With Primarily Unresectable Liver Metastases Secondary to Colorectal Cancer Receiving Treatment With 5-FU, Leucovorin, Oxaliplatin and Bevacizumab With or Without Irinotecan as 1st Line Treatment.
- adult patients, >=18 and <=70 years of age;
- unresectable liver metastasis secondary to cancer of colon or rectum;
- scheduled for standard first line chemotherapy;
- ECOG performance score of 0 or 1;
- condition feasible for major abdominal surgery after first line treatment.
- diagnosis of metastatic disease >3 months prior to study entry;
- evidence of extrahepatic disease, diffuse peritoneal carcinosis or involvement of
celiac lymph nodes;
- prior systemic or local treatment of metastatic disease;
- prior (neo)adjuvant chemotherapy/radiotherapy completed within 6 months prior to
- history or evidence of CNS disease unrelated to cancer.
Type of Study:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Resection rate of liver metastases after neoadjuvant treatment
Outcome Time Frame:
- Colorectal Cancer
- Colorectal Neoplasms