Completed

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.

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What is being tested

Gemcitabine 2 g

+ BCG Vaccine

Drug
Who is being recruted

Urogenital Diseases+12

+ Urinary Bladder Diseases

+ Carcinoma

From 18 to 85 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Other Study

Phase 2
Interventional
Study Start: September 2006
See protocol details

Summary

Principal SponsorA.O.U. Città della Salute e della Scienza
Last updated: January 30, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: September 1, 2006

Actual date on which the first participant was enrolled.

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.

NCT01697306
Principal SponsorA.O.U. Città della Salute e della Scienza
Last updated: January 30, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

120 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Other Study

Some studies explore topics that don't fall into a specific category. These might include innovative research, new technologies, or emerging healthcare areas.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 85 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesUrinary Bladder DiseasesCarcinomaFemale Urogenital Diseases and Pregnancy ComplicationsNeoplasmsNeoplasms by Histologic TypeNeoplasms by SiteNeoplasms, Glandular and EpithelialUrogenital NeoplasmsUrologic DiseasesUrologic NeoplasmsFemale Urogenital DiseasesMale Urogenital DiseasesNon-Muscle Invasive Bladder NeoplasmsUrinary Bladder Neoplasms

Criteria

5 inclusion criteria required to participate
BCG naive
WHO performance status <= 2
age <= 85years
patients not treated with intravesical chemotherapy in the last 3 months
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5 exclusion criteria prevent from participating
history of genito-urinary tuberculosis
inadequate bone marrow reserve (white blood cells < 3 x 109/l, platelets < 100 x 109/l)
preoperative urinary cytology positive for high-grade atypia
presence of T1G3 or CIS
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator
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 II

Active Comparator
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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

A.O.U. San Giovanni Battista Molinette

Torino, ItalyOpen A.O.U. San Giovanni Battista Molinette in Google Maps
CompletedOne Study Center