British stomach cancer group trial IV: A randomised trial of cimetidine treatment in gastric cancer
| ISRCTN | ISRCTN45115288 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN45115288 |
| Protocol serial number | GA3004 |
| Sponsor | Cancer Research UK (CRUK) (UK) |
| Funders | Cancer Research UK, Smithkline Beecham Pharmaceuticals |
- 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 | Oesophagus, stomach cancer |
| Intervention | Patients are randomised to one of four treatment arms: 1. Arm A: Cimetidine 400 mg twice daily until death. 2. Arm B: Cimetidine 400 mg once daily until death. 3. Arm C: Placebo tablet twice daily until death. 4. Arm D: Placebo tablet once daily until death. |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | cimeditine |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/03/1995 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | |
| Key inclusion criteria | 1. Biopsy proven adenocarcinoma of the stomach, any stage of disease, whether removed curatively or palliatively, or unresectable 2. Able to swallow tablets 3. No other concurrent cancer at other primary sites 4. No other serious illness, limiting prognosis severely |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1994 |
| Date of final enrolment | 31/03/1995 |
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 | 01/12/1999 | Yes | No |
