Perioperative chemotherapy in Liver Metastases and Colorectal Adenocarcinoma - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Drug: perioperative chemotherapy

Detailed Description

When colon or rectal cancer has spread to the liver, the cancer in the liver can sometimes be removed surgically. However, the cancer has a chance or reoccurring in the liver or elsewhere in the body. This study will determine if giving chemotherapy treatment before the surgery can reduce the chances that the cancer will come back.

Study Type

Interventional

Enrollment

70

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Alberta
  - Calgary, Alberta, Canada, T2N 4N2
    - Tom Baker Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

stage IV colorectal cancer isolated to the liver
one measurable lesion
metastases are completely resectable or amenable to ablation
Karnofsky >70
Adequate bone marrow function
adequate hepatic function
adequate renal function
informed consent

Exclusion Criteria:

primary tumor not controlled by locoregional treatments
bilateral portal vein and/or hepatic artery involvement
previous chemotherapy directed at treatment of metastatic colorectal cancer
underlying acute or chronic liver disease
Gilbert's disease
patients receiving phenytoin or phenobarbital prophylaxis
presence of any concurrent medical or psychiatric condition that serves as a contraindication to surgery or chemotherapy
pregnancy
malignancy other than basal cell or squamous cell carcinoma of the skin within the preceding 5 years
use of another investigational medication concurrently or within 4 months of enrollment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
disease free survival

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alberta Health services

Collaborators

Pfizer

Investigators

Principal Investigator: Oliver Bathe, MD, Alberta Health Services

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Bathe OF, Ernst S, Sutherland FR, Dixon E, Butts C, Bigam D, Holland D, Porter GA, Koppel J, Dowden S. A phase II experience with neoadjuvant irinotecan (CPT-11), 5-fluorouracil (5-FU) and leucovorin (LV) for colorectal liver metastases. BMC Cancer. 2009 May 20;9:156. doi: 10.1186/1471-2407-9-156.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria