Clinical trial NCT00606398: Combined Resection of Colorectal Metastases
Official title: Combined Resection of Intra- and Extra-Hepatic Metastases From Colorectal Cancer: A Phase II Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Keywords: colorectal metastases
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Sunnybrook Health Sciences Centre
First posted: 2008-02-04
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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
* Failure to meet inclusion criteria

Primary outcomes:
measure: two-year disease free survival (DFS)
timeFrame: 2 years
Secondary outcomes:
measure: 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
timeFrame: 5 years
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Alice Wei, MD, CM, MSc, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: