| Source of record | UK Trials |
| ISRCTN | ISRCTN43154562 |
| Date ISRCTN assigned | 01/07/2001 |
| Local reference number(s) | LY03 |
| Public title | Protocol for a randomised trial of triple anti-Heliocobacter therapy versus chlorambucil in an endoscopically diagnosed low grade gastric lymphoma |
| Scientific title |
|
| Acronym | Not Applicable |
| Disease/condition/study domain | Lymphoma (non-Hodgkins) |
| 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. Non-resected, partially or completely resected low grade gastric lymphoma
2. Age 16 or over |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated end date | 18/05/2001 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | Patients are randomised to one of two treatment regimens:
1. Regimen A: Colloidal bismuth 120 mg four times daily, metronidazole, 400 mg three times daily plus tetracycline 500 mg four times daily or amoxycillin 500 mg four times daily. In addition patients receive chlorambucil daily for 14 days, cycle to be repeated every 28 days for six cycles.
2. Regimen B: Colloidal bismuth 120 mg four times daily, metronidazole, 400 mg three times daily plus tetracycline 500 mg four times daily or amoxycillin 500 mg four times daily. No chlorambucil. |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Cancer Research UK |
| Sponsor name | Cancer Research UK |
| Sponsor details | PO Box 123
Lincoln's Inn Fields
London
United Kingdom
WC2A 3PX |
| Sponsor telephone | +44 (0)20 7317 5186 |
| Sponsor fax | +44 (0)20 7487 4302 |
| Sponsor email | kate.law@cancer.org.uk |
| Sponsor website | http://www.cancer.org.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 | ISRCTN43154562 |
| Date last extracted from ISRCTN register | 17/04/2008 |
