Condition category
Cancer
Date applied
06/04/2000
Date assigned
06/04/2000
Last edited
31/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Dionne Cain

ORCID ID

Contact details

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00002692

Protocol/serial number

CR05

Study information

Scientific title

Acronym

Study hypothesis

To compare the efficacy and safety of intravenous and intrahepatic arterial infusion of 5-FU and leucovorin.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Colorectal cancer

Intervention

Intrahepatic arterial infusion of 5-FU/leucovorin

Intervention type

Drug

Phase

Not Specified

Drug names

fluorouracil, leucovorin calcium

Primary outcome measures

Survival time

Secondary outcome measures

Quality of life, objective tumour response, duration of response, toxicity.

Overall trial start date

16/12/1994

Overall trial end date

31/08/2000

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

290

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

16/12/1994

Recruitment end date

31/08/2000

Locations

Countries of recruitment

United Kingdom

Trial participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Medical Research Council (MRC) (UK)

Sponsor details

20 Park Crescent
London
W1B 1AL
United Kingdom
+44 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12573372

Publication citations

  1. Results

    Kerr DJ, McArdle CS, Ledermann J, Taylor I, Sherlock DJ, Schlag PM, Buckels J, Mayer D, Cain D, Stephens RJ, , , Intrahepatic arterial versus intravenous fluorouracil and folinic acid for colorectal cancer liver metastases: a multicentre randomised trial., Lancet, 2003, 361, 9355, 368-373, doi: 10.1016/S0140-6736(03)12388-4.

Additional files

Editorial Notes