Adjuvant treatment of gastric cancer with preoperative intraperitoneal mitomycin-C bound to carbon particles
| ISRCTN | ISRCTN65411483 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65411483 |
| Protocol serial number | MMC-CH |
| Sponsor | Leicester General Hospital (UK) |
| Funder | Leicester General Hospital (UK) |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 24/10/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
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
Contact information
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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 |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Mitomycin-C, cimetidine |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/1995 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| 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 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
24/10/2019: No publications found. All search options exhausted.
05/01/2016: no publications found on PubMed.
