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

ISRCTN	ISRCTN11318989
DOI	https://doi.org/10.1186/ISRCTN11318989
Protocol serial number	BA07
Sponsor	Medical Research Council (MRC) (UK)
Funder	Medical Research Council (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr - -
Scientific

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific 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
Study objectives	Not provided at time of registration.
Ethics approval(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	Bladder (advanced)
Intervention	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.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Methotrexate and Vinblastine with Cisplatin
Primary outcome measure(s)	Not provided at time of registration.
Key secondary outcome measure(s)	Not provided at time of registration.
Completion date	31/07/1995

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Key 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
Key exclusion criteria	Not provided at time of registration.
Date of first enrolment	01/07/1990
Date of final enrolment	31/07/1995

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/10/1998	24/10/2019	Yes	No

24/10/2019: Publication reference added.