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
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