| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN42493631 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | COLO 1 |
| Public title | A Randomised Trial Comparing the Efficacy of Infusional 5-Fluorouracil (5-FU) to 5-FU plus Alpha Interferon in Patients with Unresectable Colorectal Cancer |
| 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. Histological evidence of metastatic adenocarcinoma of the colon or rectum not amenable to surgery or radiotherapy
2. Patients evaluable for response must have bi-dimensionally measurable disease
3. Patients with no measurable disease
4. No prior treatment with 5-fluorouracil or other cyctotoxic agent or interferon
5. Adequate bone marrow function
6. Life expectancy of greater than 3 months
7. Eastern Cooperative Oncology Group (ECOG) performance status 0-2
8. No history of other malignant disease other than non melanotic skin cancer or carcinoma in situ of the cervix
9. No intracerebral metastases or meningeal carcinomatosis
10. No medical contraindications to treatment |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/01/2002 |
| Anticipated end date | 31/12/2002 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 1. Regimen A: 5-fluorouracil, continuous intravenous infusion
2. Regimen B: 5-fluorouracil, continuous intravenous infusion, plus alpha-interferon five mega units given subcutaneously three times a week for the duration of 5-fluorouracil treatment |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Royal Marsden Hospital NHS Trust (UK) |
| Sponsor name | Royal Marsden Hospital (UK) |
| Sponsor details | Downs Road
Sutton
United Kingdom
SM2 5PT |
| Sponsor telephone | +44 (0)20 8661 3156 |
| Sponsor fax | +44 (0)20 8643 9414 |
| Sponsor website | david.cunningham@rmh.nhs.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 | ISRCTN42493631 |
| Date last extracted from ISRCTN register | 17/04/2008 |
