Co-operative surgical trial for gastric cancer
| ISRCTN | ISRCTN13882846 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13882846 |
| Protocol serial number | ST01 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Medical Research Council (MRC) (UK) |
- Submission date
- 28/02/2001
- Registration date
- 28/02/2001
- Last edited
- 21/01/2019
- 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 James Lyddiard
Scientific
Scientific
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
| abc@email.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Co-operative surgical trial for gastric cancer |
| Study objectives | To compare the effectiveness of more radical (R2) resection to the R1 resection with respect to the endpoints. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Cancer |
| Intervention | Arm 1: conventional (R1) resection of tumour. Arm 2: radical (R2) resection of tumour. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Operative morbidity and mortality (within 6 weeks of surgery) |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/11/1993 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 400 |
| Key inclusion criteria | Histologically or cytologically proven invasive gastric adenocarcinoma (stage I-III). |
| Key exclusion criteria | The patient must not have a perforated gastric carcinoma requiring emergency surgery. |
| Date of first enrolment | 01/01/1986 |
| Date of final enrolment | 01/11/1993 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | preliminary results | 13/04/1996 | Yes | No | |
| Results article | 5-year survival results | 01/03/1999 | Yes | No |
Editorial Notes
21/01/2019: Publication reference added.
