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

January 28, 2025 updated by: Marco Oderda, A.O.U. Città della Salute e della Scienza

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • TO
      • Torino, TO, Italy, 10126
        • A.O.U. San Giovanni Battista Molinette

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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
Drug: Gemcitabine 2 g
six weekly instillations of gemcitabine (Gemzar, Eli Lilly SpA), 2.000 mg diluted in 50 cc of saline
Other Names:
  • Gemzar, Eli Lilly SpA
Active Comparator: 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
Drug: BCG Vaccine
six weekly instillations of Connaught strain BCG (Immucyst) 1/3 dose (27 mg) diluted in 50 cc of saline
Other Names:
  • BCG Connaught 1/3 dose

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
quality of life of intermediate-risk NMIBC patients treated with intravesical Gemcitabine chemotherapy or BCG
Time Frame: 1 year
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
comparison of the short term efficacy of the two treatments in terms of recurrence
Time Frame: 1 year
1 year
comparison of the short term efficacy of the two treatments in terms of progression
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
A.O.U. Città della Salute e della Scienza

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Turin, Italy
Universitätsklinikum Hamburg-Eppendorf
University of Eastern Piedmont

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Paolo Gontero, Professor, A.O.U. San Giovanni Battista Molinette

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2006

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 27, 2012

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CE 70/06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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