| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN18439984 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | MA2B3002 |
| Public title | A Prospective Randomised Multicentre Phase III Clinical Trial Comparing the Effects of Panorex Injection Plus 5-Fluorouracil (5-FU)/Leucovorin versus 5-Fluorouracil/Leucovorin versus PANOREX alone, in patients with Surgically resected Stage III (Dukes C) Carcinoma of the Colon |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Colon cancer |
| 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. Histopathologically documented stage III (Dukes C) colon cancer
2. Less than 6 weeks since surgical removal of the tumour
3. Tumour-free margin of resection
4. Total resection of tumour by laparoscopy is an exclusion
5. Age >18: World Health Organisation (WHO) performance status of 0, 1 or 2: Life expectancy at least 12 months
6. Adequate haematological, hepatic and renal function
7. No metastatic, recurrent, locally advanced cancer or previous history of cancer |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/01/1998 |
| Anticipated end date | 12/03/1999 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 1. Arm 1: Panorex (900 mg) (1 x 500 mg 5-FU, 4 x 100 mg Luecovorin)
2. Arm 2: 5-FU - 425 mg/m2/d x 5 days for six courses; Leucovorin - 20 mg.m2/day x 5 days for six courses
3. Arm 3: Panorex alone (900 mg) |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | GlaxoSmithKline |
| Sponsor name | Glaxo Wellcome (UK) |
| Sponsor details | Stockley Park West
Uxbridge, Middlesex
United Kingdom
UB11 1BT |
| Sponsor website | http://uk.gsk.com |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN18439984 |
| Date last extracted from ISRCTN register | 17/04/2008 |
