Bladder Cancer Clinical Trial
Official title:
The Impact of Intravesical Gemcitabine and 1/3 Dose Bacillus-Calmette Guerin (BCG) Instillation Therapy on the Quality of Life in Non-muscle-invasive Bladder Cancer (NMIBC) Patients: Results of a Prospective, Randomised Phase II Trial.
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.
Status | Completed |
Enrollment | 120 |
Est. completion date | May 2012 |
Est. primary completion date | March 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 85 Years |
Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Italy | A.O.U. San Giovanni Battista Molinette | Torino | TO |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera San Giovanni Battista | Universitätsklinikum Hamburg-Eppendorf, University of Eastern Piedmont, University of Turin, Italy |
Italy,
Martínez-Piñeiro JA, Martínez-Piñeiro L, Solsona E, Rodríguez RH, Gómez JM, Martín MG, Molina JR, Collado AG, Flores N, Isorna S, Pertusa C, Rabadán M, Astobieta A, Camacho JE, Arribas S, Madero R; Club Urológico Español de Tratamiento Oncológico (CUETO). Has a 3-fold decreased dose of bacillus Calmette-Guerin the same efficacy against recurrences and progression of T1G3 and Tis bladder tumors than the standard dose? Results of a prospective randomized trial. J Urol. 2005 Oct;174(4 Pt 1):1242-7. — View Citation
Porena M, Del Zingaro M, Lazzeri M, Mearini L, Giannantoni A, Bini V, Costantini E. Bacillus Calmette-Guérin versus gemcitabine for intravesical therapy in high-risk superficial bladder cancer: a randomised prospective study. Urol Int. 2010;84(1):23-7. doi: 10.1159/000273461. Epub 2010 Feb 17. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | quality of life of intermediate-risk NMIBC patients treated with intravesical Gemcitabine chemotherapy or BCG | 1 year | Yes | |
Secondary | comparison of the short term efficacy of the two treatments in terms of recurrence | 1 year | No | |
Secondary | comparison of the short term efficacy of the two treatments in terms of progression | 1 year | No |
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