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

• Status: Completed
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Azienda Ospedaliera San Giovanni Battista
• Collaborators: Universitätsklinikum Hamburg-Eppendorf; University of Eastern Piedmont; University of Turin, Italy
• Treatments: BCG Vaccine; Gemcitabine

Criteria

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.