Adjuvant vs. Progression-Triggered Treatment With Gemcitabine After Radical Cystectomy for Locally Advanced Transitional Cell Carcinoma of the Bladder in Patients Not Suitable for Cisplatin-Based Chemotherapy - A Phase 3 Study
- To analyse time to tumor progression in patients cystectomized for locally advanced TCC
of the bladder, who are not suitable for cisplatin-based chemotherapy (i.e.
postoperative reduced renal function, advanced age). Patients are randomized to receive
either adjuvant Gemcitabine immediately after radical operation (treatment arm A) or no
treatment (control arm B). Patients in the control arm are to be treated with
Gemcitabine as soon as tumor progression becomes evident clinically and/or
The secondary objectives of this study are:
- Estimation of time-specific survival probabilities irrespective of causes of death.
- Assessment of toxicity and tolerability of Gemcitabine
- Description of survival experience of patients in the control arm beyond the time of
- Assessment of quality of life (EORTC QLQ-C30).
This is an open-label, prospective, multicenter, randomized, controlled phase 3 two-arm
study using Gemcitabine as a single agent in chemonaive cystectomy patients with locally
advanced TCC of the bladder in an adjuvant setting. The patients will receive the following
Arm A (treatment): Gemcitabine 1250 mg/m2 intravenously once a week for 2 weeks (days 1 and
8) followed by 1-week rest period. Repeat cycle on day 22. Maximum of 6 cycles. Begin
treatment until 3 months after radical operation (within first 6 weeks is recommended).
Arm B (control): No immediate post-surgery treatment. Watchful waiting; treatment only
conditionally in case of progression with Gemcitabine (dose and schedule as in arm A).
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Michael Stöckle, MD
Dept of Urology, Saarland University
Germany: Federal Institute for Drugs and Medical Devices