Combined Resection of Colorectal Metastases

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00606398

Acronym

CRC

Enrollment

Registered

2008-02-04

Start date

2007-06-30

Completion date

2014-01-31

Last updated

2014-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Keywords

colorectal metastases

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.

Interventions

PROCEDUREsurgical 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 design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
two-year disease free survival (DFS)	2 years

Secondary

Measure	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

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026