Combined Resection of Colorectal Metastases (CRC)
|Colorectal Cancer||Procedure: surgical resection for patients with both intra- and extra-hepatic metastases||Phase 2|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||Combined Resection of Intra- and Extra-Hepatic Metastases From Colorectal Cancer: A Phase II Trial|
- two-year disease free survival (DFS) [ Time Frame: 2 years ]
- Overall survival rate (OS), patterns of treatment failure, treatment efficacy (R0 resection rate), peri-operative morbidity and mortality rates, health related quality of life, hospital length of stay [ Time Frame: 5 years ]
|Study Start Date:||June 2007|
|Study Completion Date:||January 2014|
|Primary Completion Date:||December 2007 (Final data collection date for primary outcome measure)|
Procedure: surgical resection for patients with both intra- and extra-hepatic 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00606398
|University Health Network|
|Toronto, Ontario, Canada, M5G 2C4|
|Principal Investigator:||Alice Wei, MD, CM, MSc, FRCSC||University Health Network, Toronto|