| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN43866427 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | RMH E/C 1040 |
| Public title | A Randomised study of continuous Infusional 5-Fluorouracil (5FU) with or without bolus Mitomycin-C in patients with advanced oesophago-gastric cancer |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Oesophagus, Stomach |
| 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 carcinoma of the oesophagus or stomach
2. Histological evidence of locally advanced oesophageal or gastric carcinoma, not amenable to surgery or radiotherapy and for whom high dose chemotherapy or more intensive chemotherapy is not appropriate, normally around the age of 60 |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated end date | 31/03/2001 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | Two Arms:
1. Portal Vein Infusion (PVI) 5FU 300 mg/m2/day over 24 weeks
2. PVI 5FU 300 mg/m2/day over 24 weeks + Mitomycin-c 7 mg/m2 (total dose no more than 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 | ISRCTN43866427 |
| Date last extracted from ISRCTN register | 17/04/2008 |
