Combined Resection of Colorectal Metastases (CRC)

• ClinicalTrials.gov Identifier: NCT00606398
• Recruitment Status: Completed
• First Posted: February 4, 2008
• Last Update Posted: January 27, 2014
• Sponsor: University Health Network, Toronto
• Collaborator: Sunnybrook Health Sciences Centre
• Information provided by: University Health Network, Toronto

Tracking Information

• First Submitted Date: January 21, 2008
• First Posted Date: February 4, 2008
• Last Update Posted Date: January 27, 2014
• Study Start Date: June 2007
• Actual Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 1, 2008): two-year disease free survival (DFS) [ Time Frame: 2 years ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: January 24, 2014): 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 ]
• Original Secondary Outcome Measures (submitted: February 1, 2008): Overall survival rate (OS), patterns of treatment failure, treatment efficacy (R0 resection rate), peri-operative morbidity and mortality rates, helath related quality of life, hospital length of stay [ Time Frame: 5 years ]
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Combined Resection of Colorectal Metastases
• Official Title: Combined Resection of Intra- and Extra-Hepatic Metastases From Colorectal Cancer: A Phase II Trial
• Brief Summary: 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.

Detailed Description

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
• Study Phase: Phase 2
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Colorectal Cancer

Intervention

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

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: February 1, 2008): 56
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: January 2014
• Actual Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Canada

Administrative Information

• NCT Number: NCT00606398
• Other Study ID Numbers: GIAW1
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Dr. Alice Wei, UHN
• Study Sponsor: University Health Network, Toronto
• Collaborators: Sunnybrook Health Sciences Centre

Investigators

• Principal Investigator: Alice Wei, MD, CM, MSc, FRCSC; University Health Network, Toronto

• PRS Account: University Health Network, Toronto
• Verification Date: January 2014