BCG vs. Gemcitabine For Intravesical Therapy In High Risk Superficial Bladder Cancer: A Randomized Prospective Study
This was a prospective, randomized study conducted from 2004 to 2006 at a single tertiary
urban teaching University Urological Department regarding sixty-four patients with high-risk
superficial bladder cancer (pT1, and/or G3 and/or CIS), who were assigned to interventions
(gemcitabine or BCG) by using random allocation 1:1. Group A, 32 patients, were treated
weekly (6 weekly instillations) with BCG dose 5 x 108 CFU and then maintenance therapy at
3-6-12-18-24-30-36 months; Group B, 32 patients, received gemcitabine 2 gr/instillation on a
weekly basis (6 weekly instillations), followed by maintenance therapy at 3-6-12-18-24-30-36
months.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
The primary outcome measure consists of evaluation of recurrence and progression rates as they were detected by follow-up tools. Interval before recurrence and progression were also considered primary end-points
No
Italy: Ministry of Health
EC_ML_003
NCT00696579
January 2004
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