| Source of record | UK Clinical Trials Gateway |
| ISRCTN | ISRCTN16638426 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | EMI Study |
| Public title | A Multicentre Randomised Feasibility Study of Adjuvant Chemotherapy (CT) following Radical Primary Treatment for Transitional Cell Carcinoma (TCC) of the Bladder |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Cancer of bladder (advanced) |
| 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 confirmed invasive TCC of the bladder
2. Stage T2, T3a, T3b, T4a, N0 or T(any), N1/N2
3. Patient has undergone a complete resection at cystectomy or has received radical radiotherapy with curative intent
4. Fit enough to undergo combination chemotherapy
5. Creatinine clearance >60ml/min within 10 weeks of primary treatment
6. Haematological counts within 4 weeks before randomisation: White Blood Count (WBC) >3x10^9/l Platelets >100 x10^9/l Haemoglobin >10g/dl
7. Patient must be able to commence CT within 12 weeks of completion of primary treatment
8. Written informed consent |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/01/2000 |
| Anticipated end date | 15/02/2002 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | Total Cystectomy or Radical RT +/- CT
CT: Methotrexate 30 mg/m^2 (days 1, 15, 22) Vinblastine 3 mg/m^2 (days 2, 15, 22) Adriamycin 30 mg/m2 (day 2) Cisplatin 70 mg/m2 (day 2) every 28 days, maximum of three cycles |
| Primary outcome measure(s) | Not provided at time of registration |
| Secondary outcome measure(s) | Not provided at time of registration |
| Publications | ReFeR results in http://www.refer.nhs.uk/ViewRecord.asp?ID=1138 |
| Sources of funding | Northern Research and Development (UK) |
| Sponsor name | Northern Research and Development (UK) |
| Sponsor details | -
Durham
United Kingdom
- |
| Contact name | Dr - - |
| Contact details | UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
United Kingdom
NW1 2DA |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN16638426 |
| Date last extracted from ISRCTN register | 17/04/2008 |
