Combined Resection of Colorectal Metastases

Phase 2

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT00606398
• Lead Sponsor: University Health Network, Toronto

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 Timeline

• Study Start: 2007-06
• Primary Completion: 2007-12
• Study First Submitted: 2008-01-21
• Study First Submitted QC: 2008-02-01
• Study First Posted: 2008-02-04
• Status Verified: 2014-01
• Study Completion: 2014-01
• Last Update Submitted: 2014-01-24
• Last Update Posted: 2014-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
two-year disease free survival (DFS)	2 years

Secondary Outcome Measures

Name	Time	Method
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	5 years

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada