Gemcitabine and Docetaxel Therapy in High-risk BCG-naive Patients With Non-muscle Invasive Bladder Cancer

NCT ID: NCT05671900

Last Updated: 2024-03-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-01

Study Completion Date

2024-12-31

Brief Summary

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Bacillus Calmette-Guerin (BCG) is the standard of care for high-risk patients with non-muscle invasive bladder cancer (NMIBC) after transurethral tumor resection. Since 2012, global BCG shortage encouraged the search of alternative treatment for NMIBC treatment. Intravesical gemcitabine and docetaxel chemotherapy (GEM/DOCE) has shown safety and efficacy in 2 retrospective, single institution cohorts. At our institution, GEM/DOCE has been offered as an option for NMIBC in the treatment of high-risk BCG-naive patients per the protocol adapted from University of Iowa, in shortage situation. Our objective is to evaluate the efficacy of GEM/DOCE therapy.

Detailed Description

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Conditions

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Non-muscle-invasive Bladder Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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All patients

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Group Type EXPERIMENTAL

Gemcitabine 1000 mg, Docetaxel 37.5g

Intervention Type DRUG

6 weekly instillations of gemcitabine (1 gram of gemcitabine in 50 ml of sterile water) followed immediately by docetaxel (37.5 mg of docetaxel in 50 mL of saline) and subsequent monthly maintenance installations for those with no evidence of disease.

Interventions

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Gemcitabine 1000 mg, Docetaxel 37.5g

6 weekly instillations of gemcitabine (1 gram of gemcitabine in 50 ml of sterile water) followed immediately by docetaxel (37.5 mg of docetaxel in 50 mL of saline) and subsequent monthly maintenance installations for those with no evidence of disease.

Intervention Type DRUG

Other Intervention Names

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Sequential intravesical chemotherapy GEM/DOCE

Eligibility Criteria

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Inclusion Criteria

* BCG-naive patients with high-risk non-muscle invasive bladder cancer

Exclusion Criteria

* patients in whome cystectomy is planned
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinical Hospital Centre Zagreb

OTHER

Sponsor Role lead

Responsible Party

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Mirko Bakula

PhD, Urologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mirko Bakula

Role: PRINCIPAL_INVESTIGATOR

UHC Zagreb

Locations

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University Hospital Centre Zagreb

Zagreb, , Croatia

Site Status

Countries

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Croatia

Other Identifiers

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81505203284

Identifier Type: -

Identifier Source: org_study_id

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