Protocol for a randomised trial of triple anti-Heliocobacter therapy versus chlorambucil in an endoscopically diagnosed low grade gastric lymphoma
| ISRCTN | ISRCTN43154562 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN43154562 |
| Protocol serial number | LY03 |
| Sponsor | Cancer Research UK (CRUK) (UK) |
| Funder | Cancer Research UK |
- Submission date
- 01/07/2001
- Registration date
- 01/07/2001
- Last edited
- 04/01/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Lymphoma (non-Hodgkins) cancer |
| Intervention | 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. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Cancer drug |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 18/05/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | |
| Key inclusion criteria | 1. Non-resected, partially or completely resected low grade gastric lymphoma 2. Age 16 or over |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1996 |
| Date of final enrolment | 18/05/2001 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2009 | Yes | No |
