The Impact of Intravesical Gemcitabine and 1/3 Dose Bacillus Calmette-Guerin on the Quality of Life in Superficial Bladder Cancer

Phase 2

Completed

• Conditions: Bladder Cancer
• Interventions: Drug: Gemcitabine 2 g; Drug: BCG Vaccine

• Registration Number: NCT01697306
• Lead Sponsor: A.O.U. Città della Salute e della Scienza

Brief Summary

To our knowledge, there are no comparative studies on bacillus Calmette-Guerin (BCG) and intravesical chemotherapy addressing quality of life (QoL) issues. The aim of this study was to prospectively evaluate and compare the QoL of intermediate-risk non-muscle-invasive (NMIBC) patients treated with BCG or gemcitabine.

Detailed Description

Intravesical Bacillus Calmette-Guérin (BCG) is considered the most effective agent for non-muscle-invasive bladder cancer (NMIBC), representing the first-line option in the management of carcinoma in situ (CIS) and high-risk disease. In intermediate-risk NMIBC, however, both BCG and intravesical chemotherapy are accepted alternative adjuvant options since the superiority of BCG has been only established for disease recurrence but not progression and it needs to be balanced against higher toxicity. According to current evidence, BCG is considered less tolerable than intravesical chemotherapy such as mitomycin-C or doxorubicin, based on reported side effects. Among chemotherapeutic agents, gemcitabine has an excellent toxicity profile and promising efficacy in NMIBC patients, including those at high-risk of disease recurrence, even if its role on the management of NMIBC has not been well-defined yet. To our knowledge, there are no comparative studies on BCG and intravesical chemotherapy addressing quality of life (QoL) issues. The aim of this study was to prospectively evaluate and compare the QoL of intermediate-risk NMIBC patients treated with BCG or gemcitabine.

Study Timeline

• Study Start: 2006-09
• Primary Completion: 2011-03
• Study Completion: 2012-05
• Status Verified: 2012-09
• Study First Submitted: 2012-09-21
• Study First Submitted QC: 2012-09-27
• Study First Posted: 2012-10-02
• Last Update Submitted: 2025-01-28
• Last Update Posted: 2025-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• patients with clinical evidence of intermediate-risk non-muscle invasive bladder cancer (namely Ta-1, G1-2, multifocal or unique and recurrent, >3 cm in diameter)
• WHO performance status ≤2
• age ≤85years
• BCG naive
• patients not treated with intravesical chemotherapy in the last 3 months.

Exclusion Criteria

• presence of T1G3 or CIS
• preoperative urinary cytology positive for high-grade atypia
• inadequate bone marrow reserve (white blood cells <3 x 109/l, platelets <100 x 109/l)
• history of genito-urinary tuberculosis
• presence of uncontrolled urinary infections.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gemcitabine-arm	Gemcitabine 2 g	7-15 days after TUR patients received six weekly instillations of gemcitabine (Gemzar, Eli Lilly SpA), 2.000 mg diluted in 50 cc of saline. Maintenance consisted in monthly instillations up to 1 year
BCG-arm	BCG Vaccine	7-15 days after TUR patients received an induction cycle of six weekly instillations of Connaught strain Bacillus Calmette-Guerin (BCG Immucyst) 1/3 dose (27 mg) diluted in 50 cc of saline. Maintenance consisted of 3 weekly instillations at 3, 6 and 12 months

Primary Outcome Measures

Name	Time	Method
quality of life of intermediate-risk NMIBC patients treated with intravesical Gemcitabine chemotherapy or BCG	1 year

Secondary Outcome Measures

Name	Time	Method
comparison of the short term efficacy of the two treatments in terms of recurrence	1 year
comparison of the short term efficacy of the two treatments in terms of progression	1 year

Trial Locations

Locations (1)

A.O.U. San Giovanni Battista Molinette; 🇮🇹 Torino, TO, Italy