Contact information
Type
Scientific
Primary contact
Dr James Lyddiard
ORCID ID
Contact details
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
-
abc@email.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ST01
Study information
Scientific title
Co-operative surgical trial for gastric cancer
Acronym
Study hypothesis
To compare the effectiveness of more radical (R2) resection to the R1 resection with respect to the endpoints.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Not Specified
Patient information sheet
Condition
Cancer
Intervention
Arm 1: conventional (R1) resection of tumour.
Arm 2: radical (R2) resection of tumour.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. 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 measures
Not provided at time of registration
Overall trial start date
01/01/1986
Overall trial end date
01/11/1993
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Histologically or cytologically proven invasive gastric adenocarcinoma (stage I-III).
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
400
Participant exclusion criteria
The patient must not have a perforated gastric carcinoma requiring emergency surgery.
Recruitment start date
01/01/1986
Recruitment end date
01/11/1993
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 1996 preliminary results in https://www.ncbi.nlm.nih.gov/pubmed/8606613
2. 1999 5-year survival results in https://www.ncbi.nlm.nih.gov/pubmed/10188901