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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06374914

Enrollment

120

Registered

2024-04-19

Start date

2024-04-09

Completion date

2026-04-09

Last updated

2024-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BCG, Bladder Cancer, Docetaxel, Gemcitabine, Intravesical Instillation

Keywords

bladder cancer, BCG, Intravesical Instillation, Gemcitabine, Docetaxel

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.

Interventions

DRUGIntravesical 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

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Turkey (Türkiye)

Contacts

Primary ContactMuhammed Selcuk Ozer, Medical Doctor

mseljukozer@gmail.com+905543078941

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026