A Phase 2 interventional study of surgical resection for patients with both intra- and extra-hepatic metastases in Colorectal Cancer, sponsored by University Health Network, Toronto. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-01-27.
Sponsored by University Health Network, Toronto · Phase 2, Interventional, and Treatment
This is a Phase II study of combined surgical resection for patients with both intra- and extra-hepatic metastases from colorectal cancer. The primary objective is to determine the two-year disease free survival (DFS) of patients who undergo surgical resection of both intra- and extra-hepatic metastases from colorectal cancer. The secondary objectives are to determine the overall survival rate (OS), patterns of treatment failure, treatment efficacy (R0 resection rate), peri-operative morbidity and mortality rates, health related quality of life, and hospital length of stay.
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.
5,734 studies on the registry are indexed under Colorectal Neoplasms; 1,481 are open to participants now.
This study's planned enrollment of 56 is below the median of 77 across 4,222 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →University Health Network, Toronto is the lead sponsor of 1,432 studies on the registry; 292 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
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Exclusion Criteria:
Simultaneous resection with R0 intent of intra-abdominal metastases from CRC. For patients with extra-abdominal disease, sequential resection will be permitted
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
The record gives a start of Jun 2007, a primary completion of Dec 2007 and a completion of Jan 2014. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Jan 2014. You cannot join it, but the record below documents what was studied.
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University Health Network, Toronto →