ISRCTN ISRCTN13882846
DOI https://doi.org/10.1186/ISRCTN13882846
Secondary identifying numbers ST01
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

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Email abc@email.com

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeNot Specified
Scientific titleCo-operative surgical trial for gastric cancer
Study objectivesTo 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) studiedCancer
InterventionArm 1: conventional (R1) resection of tumour.
Arm 2: radical (R2) resection of tumour.
Intervention typeOther
Primary outcome measure1. Operative morbidity and mortality (within 6 weeks of surgery)
2. Post-operative sequelae
3. Survival - with and without evidence of cancer
4. Local recurrence
5. Site and distribution of metastatic disease
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/1986
Completion date01/11/1993

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants400
Key inclusion criteriaHistologically or cytologically proven invasive gastric adenocarcinoma (stage I-III).
Key exclusion criteriaThe patient must not have a perforated gastric carcinoma requiring emergency surgery.
Date of first enrolment01/01/1986
Date of final enrolment01/11/1993

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone +44 (0)20 7636 5422
Email clinical.trial@headoffice.mrc.ac.uk
Website http://www.mrc.ac.uk

Funders

Funder type

Research council

Medical Research Council (MRC) (UK)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.