Clinical trial NCT01697306: The Impact of Intravesical Gemcitabine and 1/3 Dose Bacillus Calmette-Guerin on the Quality of Life in Superficial Bladder Cancer
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Bladder Cancer
Keywords: non muscle invasive bladder cancer
Lead sponsor: A.O.U. Città della Salute e della Scienza
Sponsor class: OTHER
Collaborators: name: University of Turin, Italy
name: Universitätsklinikum Hamburg-Eppendorf
name: University of Eastern Piedmont
First posted: 2012-10-02
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility 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.

Primary outcomes:
measure: quality of life of intermediate-risk NMIBC patients treated with intravesical Gemcitabine chemotherapy or BCG
timeFrame: 1 year
Secondary outcomes:
measure: comparison of the short term efficacy of the two treatments in terms of recurrence
timeFrame: 1 year
measure: comparison of the short term efficacy of the two treatments in terms of progression
timeFrame: 1 year
Other outcomes:
Locations:
city: Torino
country: Italy
facility: A.O.U. San Giovanni Battista Molinette
state: TO
Study officials:
affiliation: A.O.U. San Giovanni Battista Molinette
name: Paolo Gontero, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martinez-Pineiro JA, Martinez-Pineiro L, Solsona E, Rodriguez RH, Gomez JM, Martin MG, Molina JR, Collado AG, Flores N, Isorna S, Pertusa C, Rabadan M, Astobieta A, Camacho JE, Arribas S, Madero R; Club Urologico Espanol de Tratamiento Oncologico (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. doi: 10.1097/01.ju.0000173919.28835.aa.
citation: Porena M, Del Zingaro M, Lazzeri M, Mearini L, Giannantoni A, Bini V, Costantini E. Bacillus Calmette-Guerin 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.