| Source of record | UK Trials |
| ISRCTN | ISRCTN11318989 |
| Date ISRCTN assigned | 19/08/2002 |
| Local reference number(s) | BA07 |
| Public title | A Randomised Trial to Compare the Effects of Methotrexate and Vinblastine with Cisplatin, Methotrexate and Vinblastine in the Treatment of T4b, Locally Recurrent and Metastatic Transitional Cell Carcinoma |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | 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. Transitional cell carcinoma (which may contain elements of squamous or adenocarcinoma) arising from a primary at any site in the urinary tract, and in one of the following groups: Initial presentation with stage T4b disease only: Localised invasive pelvic relapse after definitive radiotherapy (when cystectomy not possible or refused): Metastatic disease at any site (patients with completely resected metastases, including those with pelvic nodes, are eligible)
2. Glomerular filtration rate of more than 50 ml/min. Patients with impaired urinary function secondary to ureteric obstruction may have this relieved with stents or ureterostomy. If renal function then recovers the patients will be eligible
3. Adequate haematological function
4. No previous systemic chemotherapy
5. No concomitant or previous malignancy other than basal cell carcinoma of the skin or carcinoma in situ of the cervix
6. No medical contraindications to treatment protocols |
| Participants - exclusion criteria | Not provided at time of registration. |
| Patient information material |
|
| Anticipated start date | 01/07/1990 |
| Anticipated end date | 31/07/1995 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration. |
| Interventions | Patients are randomised to one of two treatment arms:
1. Arm A: Chemotherapy with methotrexate and vinblastine to be repeated every 21 days for a maximum of six cycles.
2. Arm B: Chemotherapy with cisplatin, methotrexate and vinblastine to be repeated every 21 days for a maximum of six cycles. |
| Primary outcome measure(s) | Not provided at time of registration. |
| Secondary outcome measure(s) | Not provided at time of registration. |
| Sources of funding | Medical Research Council (UK) |
| Sponsor name | Medical Research Council (UK) |
| Sponsor details | 20 Park Crescent
London
United Kingdom
W1B 1AL |
| Sponsor telephone | +44 (0)20 7636 5422 |
| Sponsor fax | +44 (0)20 7436 6179 |
| Sponsor email | clinical.trial@headoffice.mrc.ac.uk |
| Sponsor website | http://www.mrc.ac.uk |
| 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 | ISRCTN11318989 |
| Date last extracted from ISRCTN register | 17/04/2008 |
