Combined Resection of Colorectal Metastases

This phase II clinical study will examine the outcomes of surgical therapy for patients with both intra- and extra-hepatic CRC metastases.

The treatment protocol includes surgical resection of metastases from Colorectal cancer. Multi-modality co-interventions such as chemotherapy (neo-adjuvant, or post-operative), radiofrequency ablation (RFA) and/or portal vein embolization (PVE) will be permitted.

The eligibility criteria include: patients with both intra-hepatic and extra-hepatic metastases from colorectal cancer, the number of extra-hepatic metastases must be three or less on pre-operative imaging, all metastatic deposits must be resectable with R0 intent, there must be no contra-indications to major surgery and an ECOG performance status of 0, 1 or 2.

Inclusion criteria

• Patients with both intra-hepatic and extra-hepatic metastases from colorectal cancer
• Number of extra-hepatic metastases must be 3 or less on pre-operative imaging
• All metastatic deposits must be resectable with clear margins
• No contra-indications to major surgery
• ECOG performance of 0, 1 or 2
• Age 18 or older
• Pregnant women or women of childbearing potential are eligible if they agree to use 2 methods of effective contraception during treatment protocol
• Written informed consent can be obtained

Exclusion criteria

• Colorectal primary in situ
• Four or more extra-hepatic lesions on pre-operative imaging
• Significant medical or psychiatric conditions that preclude major surgery or may interfere with patient compliance
• Patients receiving investigational drugs with unknown surgical risks
• Failure to meet inclusion criteria