Combined Resection of Colorectal Metastases

Colorectal Cancer Clinical Trial

— CRC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00606398
• Other study ID #: GIAW1
• Status: Completed
• Phase: Phase 2
• First received: January 21, 2008
• Last updated: January 24, 2014
• Start date: June 2007
• Est. completion date: January 2014

Study information

• Verified date: January 2014
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: January 2014
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University Health Network, Toronto	Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	two-year disease free survival (DFS)		2 years	No
Secondary	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	No