| Source of record | UK Trials |
| ISRCTN | ISRCTN59568483 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | RMH E/C 1475 |
| Public title | A randomised trial comparing 8 cycles of CPT11 with CPT11 until disease progression in patients with Colorectal Cancer resistant to 5-Fluorouracil (5FU) |
| 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 colon or rectum not amenable to surgery or radiotherapy
2. Documented evidence of disease progression by Computed Tomography (CT) within 24 weeks of last 5FU |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 16/10/1997 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | Two arms:
1. CPT11 350 mg/m2 IV over 30 min every 3 weeks
2. No 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 |
| 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 | ISRCTN59568483 |
| Date last extracted from ISRCTN register | 17/04/2008 |
