| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN53478221 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | RMH E/N 1169 |
| Public title | A Randomised Study of Continuous Infusional 5-Fluorouracil (5FU) with or without Mitomycin-C in patients with Neuroendocrine Tumours |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Endocrine |
| 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 neuro-endocrine tumours not amenable to surgery or radiotherapy
2. Patients evaluable for response must have bi-dimensionally measurable disease as assessed by chest X-ray or Computed Tomography (CT) scan
3. This disease must be outside previously irradiated areas |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/01/2000 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | Two Arms:
Regimen 1. Protracted venous infusion (PVI) 5FU 300 mg/m2/day over 24 weeks
Regimen 2. PVI 5FU 300 mg/m2/day over 24 weeks Mitomycin-C 7 mg/m2 (total dose must not exceed 56 mg) four courses over 24 weeks |
| 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 | ISRCTN53478221 |
| Date last extracted from ISRCTN register | 17/04/2008 |
