| Source of record | UK Trials |
| ISRCTN | ISRCTN27478455 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | COMBAT COIRE |
| Public title | A randomised study of continuous infusional 5-fluorouracil with or without bolus mitomycin-C in patients with advanced colorectal cancer |
| Scientific title |
|
| Acronym | Not Applicable |
| Disease/condition/study domain | Colon, Rectal cancer |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | No ethics approval information required 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. Adequate bone marrow function
5. Serum creatinine within normal range
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 prior treatment with any cytotoxic agent except adjuvant chemotherapy completed more than 12 months from randomisation
10. No intracerebral metastases or meningeal carcinomatosis
11. No medical contraindications to treatment |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 13/03/1995 |
| Anticipated end date | 13/03/1996 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 1. Regimen one: continuous infusion 5-fluorouracil. The infusion will be given for 12 weeks and for a further 12 weeks in responding patients or patients with stable disease.
2. Regimen two: continuous infusion 5-fluorouracil given as above plus mitomycin-C given every 6 weeks for two courses and to a total of four courses in responding patients or patients with stable disease. |
| 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 | ISRCTN27478455 |
| Date last extracted from ISRCTN register | 17/04/2008 |
