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

NCT01697306 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-01-30

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Gemcitabine 2 g

six weekly instillations of gemcitabine (Gemzar, Eli Lilly SpA), 2.000 mg diluted in 50 cc of saline

DRUG

BCG Vaccine

six weekly instillations of Connaught strain BCG (Immucyst) 1/3 dose (27 mg) diluted in 50 cc of saline

Sponsors & Collaborators

  • University of Turin, Italy

    collaborator OTHER

  • Universitätsklinikum Hamburg-Eppendorf

    collaborator OTHER

  • University of Eastern Piedmont

    collaborator OTHER

  • A.O.U. Città della Salute e della Scienza

    lead OTHER

Principal Investigators

  • Paolo Gontero, Professor · A.O.U. San Giovanni Battista Molinette

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-09-30
Primary Completion
2011-03-31
Completion
2012-05-31

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01697306 on ClinicalTrials.gov