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

NCT ID: NCT01697306

Last Updated: 2025-01-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-09-30
• Study Completion Date: 2012-05-31

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.

Conditions

Bladder Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Gemcitabine-arm

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

Group Type: ACTIVE_COMPARATOR

Gemcitabine 2 g

Intervention Type: DRUG

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

BCG-arm

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

Group Type: ACTIVE_COMPARATOR

BCG Vaccine

Intervention Type: DRUG

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

Interventions

Gemcitabine 2 g

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

Intervention Type: DRUG

BCG Vaccine

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

Intervention Type: DRUG

Other Intervention Names

Gemzar, Eli Lilly SpA; BCG Connaught 1/3 dose

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Turin, Italy

OTHER

Sponsor Role: collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role: collaborator

University of Eastern Piedmont

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Marco Oderda

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Paolo Gontero, Professor

Role: PRINCIPAL_INVESTIGATOR

A.O.U. San Giovanni Battista Molinette

Locations

A.O.U. San Giovanni Battista Molinette

Torino, TO, Italy

Countries

Italy

References

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.

Reference Type: BACKGROUND

PMID: 16145378 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20173364 (View on PubMed)

Other Identifiers

CE 70/06

Identifier Type: -

Identifier Source: org_study_id