Combined Resection of Colorectal Metastases

NCT ID: NCT00606398

Last Updated: 2014-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2014-01-31

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sunnybrook Health Sciences Centre

OTHER

Sponsor Role: collaborator

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

UHN

Principal Investigators

Alice Wei, MD, CM, MSc, FRCSC

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

University Health Network

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

GIAW1

Identifier Type: -

Identifier Source: org_study_id