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 |
| Secondary identifying numbers | LY03 |
- 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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Cancer drug |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/1996 |
| Completion date | 18/05/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| 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
- England
- United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Cancer Research UK (CRUK) (UK)
Charity
Charity
PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
| Phone | +44 (0)207 317 5186 |
|---|---|
| kate.law@cancer.org.uk | |
| Website | http://www.cancer.org.uk |
"ROR" |
https://ror.org/054225q67 |
Funders
Funder type
Charity
Cancer Research UK
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/02/2009 | Yes | No |
