UK Hepatic Artery Pump Trial Two: Continuous Hepatic-Artery Infusion for Palliation in Colorectal Liver Metastases
ISRCTN | ISRCTN83441783 |
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DOI | https://doi.org/10.1186/ISRCTN83441783 |
Secondary identifying numbers | UKHAP2 |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 29/10/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Not Specified |
Scientific title | UK Hepatic Artery Pump Trial Two: Continuous Hepatic-Artery Infusion for Palliation in Colorectal Liver Metastases |
Study objectives | Not provided at time of registration |
Ethics approval(s) | Not provided at time of registration |
Health condition(s) or problem(s) studied | 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 |
Pharmaceutical study type(s) | |
Phase | Not Specified |
Drug / device / biological / vaccine name(s) | 5-fluorouracil and folinic acid |
Primary outcome measure | Not provided at time of registration |
Secondary outcome measures | Not provided at time of registration |
Overall study start date | 01/01/1990 |
Completion date | 01/09/1996 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Sex | Not Specified |
Target number of participants | Not provided at time of registration |
Key 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 |
Key exclusion criteria | Not provided at time of registration |
Date of first enrolment | 01/01/1990 |
Date of final enrolment | 01/09/1996 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Colon Cancer Concern (UK)
Charity
Charity
c/o Bowel Cancer UK
7 Rickett Street
London
SW6 1RU
United Kingdom
Phone | +44(0)020 7381 9711 |
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admin@bowelcanceruk.org.uk | |
Website | http://www.bowelcanceruk.org.uk/home |
https://ror.org/03ngjs524 |
Funders
Funder type
Charity
Colon Cancer Concern (UK)
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Editorial Notes
29/10/2019: No publications found. All search options exhausted.