Adjuvant Versus Progression-Triggered Gemcitabine Monotherapy for Locally Advanced Bladder Cancer
Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
Participant gender:
Summary
Primary Objective:
- To analyse time to tumor progression in patients cystectomized for locally advanced
transitional cell carcinoma (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 radiologically.
Secondary Objectives:
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
initiating chemotherapy.
- Assessment of quality of life (European Organization for Research and Treatment of
Cancer [EORTC] Quality of Life Questionnaire [QLQ]-C30).
Study Design:
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 treatment:
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).
Phase:
Phase 3
Details
Lead Sponsor:
Association of Urogenital Oncology (AUO) Association of Urologic Oncology (AUO)