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

April 16, 2024 updated by: Muhammed Selcuk Ozer, Dokuz Eylul University
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

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

Study Contact

  • Name: Muhammed Selcuk Ozer, Medical Doctor
  • Phone Number: +905543078941 +905543078941
  • Email: mseljukozer@gmail.com

Study Locations

  • Turkey
    • Other (Non U.s.)
      • Izmir, Other (Non U.s.), Turkey, 35330
        • Dokuz Eylul University Faculty of Medicine Department of Urology
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ozan Bozkurt, Professor

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

a multi-center study within the scope of the Turkish Urooncology Association

Description

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with BCG unresponsiveness and receiving intravesical gemcitabine doxetaxel
Drug: 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
Other Names:
  • Intravesical gemcitabin and docetaxel
Patients with BCG unresponsiveness and radical cystectomy performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence rate
Time Frame: 5 years
the recurrence rate after intravesical chemotherapy will be calculated
5 years
Progression rate
Time Frame: 5 years
the progression rate after intravesical chemotherapy will be calculated
5 years
Adverse effects of intravesical chemotherapy
Time Frame: 5 years
the patients' data will be retrospectively analyzed to investigate the side effects of intravesical chemotherapy
5 years
Intravesical chemotherapy versus radical cystectomy
Time Frame: 5 years
the long-term cancer specific survival, overal survival, recurrence free survival of patients with similar pathological characteristics and who underwent radical cystectomy and patients who were given intravesical chemotherapy will be compared
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
treatment change
Time Frame: 5 years
patient transitions from intravesical chemotherapy to other treatment options will be calculated
5 years

Collaborators and Investigators

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

Sponsor

Dokuz Eylul University

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 (Estimated)

April 9, 2024

Primary Completion (Estimated)

April 9, 2026

Study Completion (Estimated)

April 9, 2026

Study Registration Dates

First Submitted

April 16, 2024

First Submitted That Met QC Criteria

April 16, 2024

First Posted (Actual)

April 19, 2024

Study Record Updates

Last Update Posted (Actual)

April 19, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TUO-UR-23-05

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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