Combined Resection of Colorectal Metastases

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Procedure: surgical resection for patients with both intra- and extra-hepatic metastases


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|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|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| two-year disease free survival (DFS) |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal metastases