| Source of record | UK Trials |
| ISRCTN | ISRCTN65411483 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | MMC-CH |
| Public title | Adjuvant Treatment of Gastric Cancer with Preoperative Intraperitoneal Mitomycin-C Bound to Carbon Particles |
| Scientific title |
|
| Acronym | Not Applicable |
| Disease/condition/study domain | Stomach |
| Study hypothesis | Not provided at time of registration |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated end date | 31/12/1995 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | 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 |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Leicester General Hospital |
| Sponsor name | Leicester General Hospital |
| Sponsor details | Gwendolen Road
Leicester
United Kingdom
LE5 4PW |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| Contact telephone | +44 (0) 20 7670 4723 |
| Contact fax | +44 (0) 20 7670 4818 |
| Contact email | register@ctu.mrc.ac.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN65411483 |
| Date last extracted from ISRCTN register | 17/04/2008 |
