UK Hepatic Artery Pump Trial Two: Continuous Hepatic-Artery Infusion for Palliation in Colorectal Liver Metastases
| ISRCTN | ISRCTN83441783 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN83441783 |
| Protocol serial number | UKHAP2 |
| Sponsor | Colon Cancer Concern (UK) |
| Funder | Colon Cancer Concern (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 5-fluorouracil and folinic acid |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/09/1996 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| 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
- United Kingdom
- England
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
29/10/2019: No publications found. All search options exhausted.
