A randomised trial of intravenous versus intrahepatic arterial 5-Flurouracil (5-FU) and leucovorin for colorectal liver metastases

Completed

• Conditions: Colorectal cancer; Cancer; Colorectal

• Registration Number: ISRCTN78734883
• Lead Sponsor: Medical Research Council (MRC) (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2000-04-06
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 290

Inclusion Criteria

1. Histologically confirmed adenocarcinoma of the colon or rectum, confined to the liver, and not amenable to surgery or found to be unresectable during surgery
2. No previous treatment with 5-FU with the exception of adjuvant therapy (eg AXIS or QUASAR studies) completed more than 12 months prior to study entry
3. Adequate bone marrow function with platelets more than 100 x 10 to the power of 9 per litre; White Blood Count (WBC) more than 3.0 x 10 to the power of 9 per litre and neutrophils more than 1.5 x 10 to the power of 9 per litre at the time of study entry
4. No concurrent uncontrolled medical illness (eg uncontrolled heart failure, angina, infection, etc)
5. Life expectancy more than 3 months
6. WHO performance status 0, 1 or 2
7. Bilirubin less than 50 micromoles per litre

Exclusion Criteria

Not provided at time of registration

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survival time

Secondary Outcome Measures

Name	Time	Method
Quality of life, objective tumour response, duration of response, toxicity.