Randomised Trial of Selective Bladder Preservation Against Radical Excision (Cystectomy) in Muscle Invasive T2/T3 Transitional Cell Carcinoma of the Bladder - Feasibility Study
- To determine the feasibility and patient acceptability of radical cystectomy vs
selective bladder preservation (SBP) after neoadjuvant chemotherapy in patients with
muscle-invasive transitional cell carcinoma of the bladder.
- To determine compliance rates of patients with their assigned treatments.
- To determine if bladder preservation is equivalent to radical cystectomy, in terms of
overall survival, in responders to neoadjuvant chemotherapy.
- To compare the overall survival of patients receiving SBP vs radical cystectomy.
- To determine the rate of salvage cystectomy in patients undergoing bladder
- To determine and compare the toxicity of treatment in both arms.
- To determine and compare quality of life of patients treated with these regimens.
- To compare locoregional progression-free and metastasis-free survival of patients
treated with these regimens.
OUTLINE: This is a multicenter study. Patients are stratified according to cancer center and
randomized to 1 of 2 treatment arms. Patients are assessed after completion of 3 courses of
pre-study neoadjuvant chemotherapy. Patients with poor response (≥ pT2, residual pT2,
macroscopic invasive tumor) undergo immediate radical cystectomy (within 6 weeks fo
completing chemotherapy). Patients* with responsive disease (≤ pT1 tumor or macroscopically
normal bladder) proceed to course 4 of chemotherapy (on-study) followed by treatment
according to randomization arm.
NOTE: *Patients with a clear bladder or those who are unsure of their histological results
prior to course 4 also proceed to chemotherapy.
- Course 4 of neoadjuvant chemotherapy: Patients receive gemcitabine hydrochloride IV
over 30 minutes on days 1 and 8 and cisplatin IV over 4 hours on day 1.
- Arm I (radical cystectomy): Patients undergo a radical cystectomy, including pelvic
lymphadenectomy, between 4 and 6 weeks after initiating course 4 of chemotherapy.
- Arm II (selective bladder preservation): Patients with no visible residual tumor (cT0
or pT0) or residual but superficial tumor (pTa, pT1) undergo radiotherapy beginning
within 4-6 weeks of day 1 of course 4 and continuing for 6.5 weeks.
Health-related quality of life is assessed periodically.
After completion of study treatment, patients are followed periodically for up to 5 years.
Allocation: Randomized, Primary Purpose: Treatment
Number of patients randomized over 3 years
Robert A. Huddart, MD
Royal Marsden NHS Foundation Trust
United States: Federal Government