A Multicentre Randomised Feasibility Study of Adjuvant Chemotherapy (CT) following Radical Primary Treatment for Transitional Cell Carcinoma (TCC) of the Bladder

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2002
INTERVENTION: 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 CONDITION: Cancer of bladder (advanced) ; Cancer ; Bladder PRIMARY OUTCOME: Not provided at time of registration SECONDARY OUTCOME: Not provided at time of registration 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
Epistemonikos ID: f119cab9178b88d24dc33760af102dd4ddb57797
First added on: Aug 21, 2024