Combined Resection of Colorectal Metastases (CRC)
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|ClinicalTrials.gov Identifier: NCT00606398|
Recruitment Status : Completed
First Posted : February 4, 2008
Last Update Posted : January 27, 2014
|Condition or disease||Intervention/treatment||Phase|
|Colorectal Cancer||Procedure: surgical resection for patients with both intra- and extra-hepatic metastases||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||56 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Combined Resection of Intra- and Extra-Hepatic Metastases From Colorectal Cancer: A Phase II Trial|
|Study Start Date :||June 2007|
|Actual Primary Completion Date :||December 2007|
|Actual Study Completion Date :||January 2014|
- Procedure: surgical resection for patients with both intra- and extra-hepatic metastases
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00606398
|University Health Network|
|Toronto, Ontario, Canada, M5G 2C4|
|Principal Investigator:||Alice Wei, MD, CM, MSc, FRCSC||University Health Network, Toronto|