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

Not yet recruiting

• Conditions: Bladder Cancer; BCG; Gemcitabine; Docetaxel; Intravesical Instillation
• Interventions: Drug: Intravesical Solution

• Registration Number: NCT06374914
• Lead Sponsor: Dokuz Eylul University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study Start: 2024-04-09
• Study First Submitted: 2024-04-16
• Study First Submitted QC: 2024-04-16
• Last Update Submitted: 2024-04-16
• Study First Posted: 2024-04-19
• Last Update Posted: 2024-04-19
• Primary Completion: 2026-04-09
• Study Completion: 2026-04-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 120

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with BCG unresponsiveness and receiving intravesical gemcitabine doxetaxel	Intravesical Solution	-

Primary Outcome Measures

Name	Time	Method
Recurrence rate	5 years	the recurrence rate after intravesical chemotherapy will be calculated
Progression rate	5 years	the progression rate after intravesical chemotherapy will be calculated
Adverse effects of intravesical chemotherapy	5 years	the patients' data will be retrospectively analyzed to investigate the side effects of intravesical chemotherapy
Intravesical chemotherapy versus radical cystectomy	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

Secondary Outcome Measures

Name	Time	Method
treatment change	5 years	patient transitions from intravesical chemotherapy to other treatment options will be calculated

Trial Locations

Locations (1)

Dokuz Eylul University Faculty of Medicine Department of Urology; 🇹🇷 Izmir, Other (Non U.s.), Turkey