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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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN11318989
Enrollment
Unknown
Registered
2002-08-19
Start date
1990-07-01
Completion date
Unknown
Last updated
2019-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bladder (advanced) Cancer 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.

Sponsors

Medical Research Council (MRC) (UK)
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Not provided at time of registration.

Design outcomes

Primary

MeasureTime frame
Not provided at time of registration.

Secondary

MeasureTime frame
Not provided at time of registration.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026