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

NCT06374914 | Not Yet Recruiting DMC FDA Drug

• 1 other identifier: TUO-UR-23-05
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer; BCG; Gemcitabine; Docetaxel; Intravesical Instillation

Keywords

bladder cancer; BCG; Intravesical Instillation; Gemcitabine; Docetaxel

Outcome Measures

Primary Outcomes (4)

• Recurrence rate

  the recurrence rate after intravesical chemotherapy will be calculated

  5 years

• Progression rate

  the progression rate after intravesical chemotherapy will be calculated

  5 years

• Adverse effects of intravesical chemotherapy

  the patients' data will be retrospectively analyzed to investigate the side effects of intravesical chemotherapy

  5 years

• 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 Outcomes (1)

• treatment change

  5 years

Study Arms (2)

Patients with BCG unresponsiveness and receiving intravesical gemcitabine doxetaxel

Drug: Intravesical Solution

Patients with BCG unresponsiveness and radical cystectomy performed

Interventions

Intravesical Solution DRUG

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

Also known as: Intravesical gemcitabin and docetaxel

Patients with BCG unresponsiveness and receiving intravesical gemcitabine doxetaxel

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

a multi-center study within the scope of the Turkish Urooncology Association

You may qualify if:

• \- BCG refractory/relapsed/unresponsive or intolerant Who do not want or are not suitable for radical cystectomy

You may not qualify if:

• \- BCG naive A history of multiple cancers Having a radical cystectomy plan

Sponsors & Collaborators

• Dokuz Eylul University: lead

Study Sites (1)

Dokuz Eylul University Faculty of Medicine Department of Urology

Izmir, Other (Non U.s.), 35330, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Docetaxel

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Central Study Contacts

Muhammed Selcuk Ozer, Medical Doctor

CONTACT

+905543078941; mseljukozer@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: April 16, 2024
• First Posted: April 19, 2024
• Study Start: April 9, 2024
• Primary Completion: April 9, 2026
• Study Completion: April 9, 2026
• Last Updated: April 19, 2024

Record last verified: 2024-04

Locations

TU (1)