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NCT06374914 Clinical Trial

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

Bladder Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06374914
Other study ID # TUO-UR-23-05
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 9, 2024
Est. completion date April 9, 2026

Study information
Verified date April 2024
Source Dokuz Eylul University
Contact Muhammed Selcuk Ozer, Medical Doctor
Phone +905543078941
Email mseljukozer@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 120
Est. completion date April 9, 2026
Est. primary completion date April 9, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 85 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Turkey Dokuz Eylul University Faculty of Medicine Department of Urology Izmir Other (Non U.s.)

Sponsors (1)
Lead Sponsor Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome
Type Measure Description Time frame Safety issue
Primary Recurrence rate the recurrence rate after intravesical chemotherapy will be calculated 5 years
Primary Progression rate the progression rate after intravesical chemotherapy will be calculated 5 years
Primary Adverse effects of intravesical chemotherapy the patients' data will be retrospectively analyzed to investigate the side effects of intravesical chemotherapy 5 years
Primary Intravesical chemotherapy versus radical cystectomy 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 treatment change patient transitions from intravesical chemotherapy to other treatment options will be calculated 5 years
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