| Source of record | UK Trials |
| ISRCTN | ISRCTN95638591 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | CR04 |
| Public title | A Randomised Trial of 5-Fluorouracil (5FU) and Leucovorin (LV) versus 5-Fluorouracil, leucovorin and Interferon-Alpha 2a for Advanced Colorectal Adenocarcinoma |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Colon, Rectum |
| Study hypothesis | Not provided at time of registration. |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration. |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Histologically confirmed adenocarcinoma of the colon or rectum not amenable to surgery or radiotherapy
2. Objectively assessable disease
3. No previous treatment with 5-fluorouracil or interferon
4. Adequate bone marrow function
5. No concurrent uncontrolled medical illness
6. Not on systemic corticosteroids at the time of study entry
7. Life expectancy of >3 months
8. World Health Organisation (WHO) performance status 0-2 |
| Participants - exclusion criteria | Not provided at time of registration. |
| Patient information material |
|
| Anticipated start date | 01/08/2000 |
| Anticipated end date | 01/08/2005 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration. |
| Interventions | Patients are randomised to one of two treatment arms:
1. Arm 5FU-LV: Chemotherapy with 5-fluorouracil and leucovorin repeated every 14 days for six cycle. Following reassessment patients receive a further six cycles of chemotherapy unless there is evidence of progressive disease.
2. Arm 5LU-LV-IFN: Chemotherapy with 5-fluorouracil and leucovorin plus interferon-alpha repeated every 14 days for six cycle. Following reassessment patients receive a further six cycles of chemotherapy unless there is evidence of progressive disease. |
| Primary outcome measure(s) | Not provided at time of registration. |
| Secondary outcome measure(s) | Not provided at time of registration. |
| Sources of funding | Medical Research Council (UK) |
| Sponsor name | Medical Research Council (UK) |
| Sponsor details | 20 Park Crescent
London
United Kingdom
W1B 1AL |
| Sponsor telephone | +44 (0)20 7636 5422 |
| Sponsor fax | +44 (0)20 7436 6179 |
| Sponsor email | clinical.trial@headoffice.mrc.ac.uk |
| Sponsor website | http://www.mrc.ac.uk |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN95638591 |
| Date last extracted from ISRCTN register | 17/04/2008 |
