Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MMC-CH
Study information
Scientific title
Adjuvant treatment of gastric cancer with preoperative intraperitoneal mitomycin-C bound to carbon particles
Acronym
Study hypothesis
Not provided at time of registration
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
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Mitomycin-C, cimetidine
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1990
Overall trial end date
31/12/1995
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1990
Recruitment end date
31/12/1995
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Funders
Funder type
Hospital/treatment centre
Funder name
Leicester General Hospital (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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