Combined Resection of Colorectal Metastases

NCT00606398 | Completed Phase 2

• 1 other identifier: GIAW1
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Cancer

Keywords

colorectal metastases

Outcome Measures

Primary Outcomes (1)

• two-year disease free survival (DFS)

  2 years

Secondary Outcomes (1)

• 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

Interventions

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

Simultaneous resection with R0 intent of intra-abdominal metastases from CRC. For patients with extra-abdominal disease, sequential resection will be permitted

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Sunnybrook Health Sciences Centre: collaborator

Study Sites (1)

University Health Network

Toronto, Ontario, M5G 2C4, Canada

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Alice Wei, MD, CM, MSc, FRCSC

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 21, 2008
• First Posted: February 4, 2008
• Study Start: June 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: January 1, 2014
• Last Updated: January 27, 2014

Record last verified: 2014-01

Locations

CA (1)