Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
05/01/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

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

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 measures

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

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

Sponsor information

Organisation

Leicester General Hospital (UK)

Sponsor details

Gwendolen Road
Leicester
LE5 4PW
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

05/01/2016: no publications found on PubMed.