Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
08/11/2012
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 - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

UKHAP2

Study information

Scientific title

Acronym

Study hypothesis

Not provided at time of registration

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

Cancer of Colon, Liver, Rectum

Intervention

1. Regimen A: Intra-hepatic continuous infusion of floxuridine for 5 days followed by systemic 5-fluorouracil and folinic acid for 5 days delivered via an arterial port-a-cath.
2. Regimen B: Systemic 5-fluorouracil and folinic acid for 5 days delivered via an arterial port-a-cath.

Intervention type

Drug

Phase

Not Specified

Drug names

5-fluorouracil and folinic acid

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/1990

Overall trial end date

01/09/1996

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged <75 years
2. Colorectal liver metastases, less than 45% liver involvement as assessed by Computed Tomography (CT) scan
3. Karnofsky score more than 80%
4. Normal Bilirubin level
5. No prior chemotherapy

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/1990

Recruitment end date

01/09/1996

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Colon Cancer Concern (UK)

Sponsor details

c/o Bowel Cancer UK
7 Rickett Street
London
SW6 1RU
United Kingdom
+44(0)020 7381 9711
admin@bowelcanceruk.org.uk

Sponsor type

Charity

Website

http://www.bowelcanceruk.org.uk/home

Funders

Funder type

Charity

Funder name

Colon Cancer Concern (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Publication citations

Additional files

Editorial Notes