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.
