A randomised trial of intravenous versus intrahepatic arterial 5-Flurouracil (5-FU) and leucovorin for colorectal liver metastases
| ISRCTN | ISRCTN78734883 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78734883 |
| ClinicalTrials.gov number | NCT00002692 |
| Secondary identifying numbers | CR05 |
- Submission date
- 06/04/2000
- Registration date
- 06/04/2000
- Last edited
- 31/07/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English Summary
Not provided at time of registration
Contact information
Dr Dionne Cain
Scientific
Scientific
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study hypothesis | To compare the efficacy and safety of intravenous and intrahepatic arterial infusion of 5-FU and leucovorin. |
| Ethics approval(s) | Not provided at time of registration |
| Condition | Colorectal cancer |
| Intervention | Intrahepatic arterial infusion of 5-FU/leucovorin |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | fluorouracil, leucovorin calcium |
| Primary outcome measure | Survival time |
| Secondary outcome measures | Quality of life, objective tumour response, duration of response, toxicity. |
| Overall study start date | 16/12/1994 |
| Overall study end date | 31/08/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 290 |
| Participant inclusion criteria | 1. Histologically confirmed adenocarcinoma of the colon or rectum, confined to the liver, and not amenable to surgery or found to be unresectable during surgery 2. No previous treatment with 5-FU with the exception of adjuvant therapy (eg AXIS or QUASAR studies) completed more than 12 months prior to study entry 3. Adequate bone marrow function with platelets more than 100 x 10 to the power of 9 per litre; White Blood Count (WBC) more than 3.0 x 10 to the power of 9 per litre and neutrophils more than 1.5 x 10 to the power of 9 per litre at the time of study entry 4. No concurrent uncontrolled medical illness (eg uncontrolled heart failure, angina, infection, etc) 5. Life expectancy more than 3 months 6. WHO performance status 0, 1 or 2 7. Bilirubin less than 50 micromoles per litre |
| Participant exclusion criteria | Not provided at time of registration |
| Recruitment start date | 16/12/1994 |
| Recruitment end date | 31/08/2000 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (MRC) (UK)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Medical Research Council (United Kingdom), UK Medical Research Council, MRC
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2003 | Yes | No |
