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ISRCTN
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ISRCTN11318989
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ClinicalTrials.gov identifier
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Public title
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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
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Scientific title
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Acronym
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N/A
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Serial number at source
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BA07
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Study hypothesis
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Not provided at time of registration.
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Ethics approval
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Not provided at time of registration.
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Bladder (advanced)
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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Not provided at time of registration.
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Anticipated start date
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01/07/1990
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Anticipated end date
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31/07/1995
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Status of trial
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Completed
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Patient information material
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Target number of participants
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Not provided at time of registration.
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Interventions
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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.
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Primary outcome measure(s)
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Not provided at time of registration.
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Secondary outcome measure(s)
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Not provided at time of registration.
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Sources of funding
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Medical Research Council (UK)
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Trial website
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Publications
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Contact name
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Dr
-
-
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Address
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UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
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City/town
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London
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Zip/Postcode
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NW1 2DA
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Country
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United Kingdom
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Tel
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+44 (0) 20 7670 4723
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Fax
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+44 (0) 20 7670 4818
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Email
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register@ctu.mrc.ac.uk
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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19/08/2002
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Last edited
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09/08/2007
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Date ISRCTN assigned
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19/08/2002
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