Sequential Intravesical Gemcitabine and Docetaxel for Rescue Therapy in BCG Unresponsive Non-muscle Invasive Bladder Cancer Patients

NCT ID: NCT06374914

Last Updated: 2024-04-19

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

NOT_YET_RECRUITING

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-09

Study Completion Date

2026-04-09

Brief Summary

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Studies in the literature are limited both throughout Turkey and in general. For this reason, as a result of the study that we will create, it will provide us with information for bladder protective treatments in patients who do not respond to BCG therapy in bladder cancer patients.

Detailed Description

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Conditions

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Bladder Cancer BCG Gemcitabine Docetaxel Intravesical Instillation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with BCG unresponsiveness and receiving intravesical gemcitabine doxetaxel

Intravesical Solution

Intervention Type DRUG

Alkalinization of urine 1 day before the procedure Emptying the bladder with a catheter before the procedure mixing 1000 mg gemcitabine in 50 ml saline 90 minutes after administration 37.5 mg docetaxel mixed 120 minutes after administration in 50 ml saline maintanence if there is a 6 week induction response

Patients with BCG unresponsiveness and radical cystectomy performed

No interventions assigned to this group

Interventions

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Intravesical Solution

Alkalinization of urine 1 day before the procedure Emptying the bladder with a catheter before the procedure mixing 1000 mg gemcitabine in 50 ml saline 90 minutes after administration 37.5 mg docetaxel mixed 120 minutes after administration in 50 ml saline maintanence if there is a 6 week induction response

Intervention Type DRUG

Other Intervention Names

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Intravesical gemcitabin and docetaxel

Eligibility Criteria

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Inclusion Criteria

\- BCG refractory/relapsed/unresponsive or intolerant Who do not want or are not suitable for radical cystectomy

Exclusion Criteria

\- BCG naive A history of multiple cancers Having a radical cystectomy plan
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dokuz Eylul University

OTHER

Sponsor Role lead

Responsible Party

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Muhammed Selcuk Ozer

Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dokuz Eylul University Faculty of Medicine Department of Urology

Izmir, Other (Non U.s.), Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Muhammed Selcuk Ozer, Medical Doctor

Role: CONTACT

+905543078941 ext. +905543078941

Facility Contacts

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Muhammed Selcuk Ozer, Medical Doctor

Role: primary

+905543078941

Ozan Bozkurt, Professor

Role: backup

Other Identifiers

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TUO-UR-23-05

Identifier Type: -

Identifier Source: org_study_id

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