Combined Resection of Intra- and Extra-Hepatic Metastases From Colorectal Cancer: A Phase II Trial
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),
radiofrequence 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
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
two-year disease free survival (DFS)
Alice Wei, MD, CM, MSc, FRCSC
University Health Network, Toronto
Canada: Ethics Review Committee