Clinical trial

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

Name

TUO-UR-23-05

Description

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.

Trial arms

Trial start

2024-04-09

Estimated PCD

2026-04-09

Trial end

2026-04-09

Status

Not yet recruiting

Treatment

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

Arms:

Patients with BCG unresponsiveness and receiving intravesical gemcitabine doxetaxel

Other names:

Intravesical gemcitabin and docetaxel

Size

120

Primary endpoint

Recurrence rate

5 years

Progression rate

5 years

Adverse effects of intravesical chemotherapy

5 years

Intravesical chemotherapy versus radical cystectomy

5 years

Eligibility criteria

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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 120, 'type': 'ESTIMATED'}}

Updated at

2024-04-19

1 organization

1 product

5 indications

Organization

Dokuz Eylul University

Product

Indication

Indication

Indication

Indication

Indication

Intravesical Instillation