Adjuvant treatment of gastric cancer with preoperative intraperitoneal mitomycin-C bound to carbon particles

ISRCTN	ISRCTN65411483
DOI	https://doi.org/10.1186/ISRCTN65411483
Secondary identifying numbers	MMC-CH

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Adjuvant treatment of gastric cancer with preoperative intraperitoneal mitomycin-C bound to carbon particles
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Stomach cancer
Intervention	1. Group A: Standard surgical resection plus 400 mg cimetidine daily for 12 months 2. Group B: Standard surgical resection with the intraperitoneal introduction of 50 mg Mitomycin-C bound to carbon particles just prior to surgical closure plus 400 mg cimetidine daily for 12 months
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Mitomycin-C, cimetidine
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/1990
Completion date	31/12/1995

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	Not provided at time of registration
Key inclusion criteria	1. Histologically documented adenocarcinoma of the stomach 2. All patients should have undergone surgery for resection of their primary malignancy 3. No evidence of distant or metastatic disease other than removable N1 or N2 lymph node metastases 4. No prior chemotherapy, radiotherapy or immunotherapy 5. Age <75 years and life expectancy greater than 3 months 6. Ambulatory performance status Karnofsky Grading 80% 7. Adequate bone marrow function 8. No evidence of organ failure 9. No evidence of intercurrent disease from previous malignancy
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/1990
Date of final enrolment	31/12/1995

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Leicester General Hospital (UK)
Hospital/treatment centre

Gwendolen Road
Leicester
LE5 4PW
England
United Kingdom

"ROR"	https://ror.org/02zg49d29

Hospital/treatment centre

Leicester General Hospital (UK)

No information available

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

24/10/2019: No publications found. All search options exhausted.
05/01/2016: no publications found on PubMed.