| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN21284267 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | SAFFA |
| Public title | A Pilot Randomised Trial Comparing Short Course Infusional 5-Fluourouracil with 5-Fluorouracil and Leucovorin as Adjuvant Therapy for Resected Colorectal Carcinoma |
| Scientific title |
|
| Acronym | Not Applicable |
| 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 verified adenocarcinoma of colon or rectum, Dukes stages B or C
2. No evidence of residual local disease or metastatic disease as assessed at time of operation, clinical examination, and by ultrasound scanning
3. No past history of malignancy apart from non melanotic carcinoma of the skin or in-situ carcinoma of the cervix
4. No previous chemotherapy
5. Normal bone marrow, renal and liver function
6. Patients must be randomised within 10 weeks of surgery
7. No medical contraindications to treatment |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 19/08/1993 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 1. Regimen A: Continuous infusion of 5-fluorouracil over 12 weeks.
2. Regimen B: Folinic acid intravenous bolus injection, followed by 5-fluorouracil intravenous bolus injection given on 5 consecutive days and repeated every 28 days for six cycles |
| 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 |
| 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 | ISRCTN21284267 |
| Date last extracted from ISRCTN register | 17/04/2008 |
