NCT06374914

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 120 (estimated)
• Sponsor: Dokuz Eylul University · Academic / Other
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bladder Cancer
• BCG
• Gemcitabine
• Docetaxel
• Intravesical Instillation

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-04-09
• Primary completion: 2026-04-09
• Completion: 2026-04-09
• First posted: 2024-04-19
• Last updated: 2024-04-19

Locations

1 site across 1 country: Turkey (Türkiye)

Regulatory

• FDA-regulated drug study