Combined Resection of Colorectal Metastases (CRC)

University Health Network, Toronto

Status and phase

Completed

Phase 2

Conditions

Colorectal Cancer

Treatments

Procedure: surgical resection for patients with both intra- and extra-hepatic metastases

Study type

Interventional

Funder types

Other

Identifiers

NCT00606398

GIAW1

Details and patient eligibility

About

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.

Full 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.

Enrollment

56 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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