Bladder CancerNCT06374914
Sequential Intravesical Gemcitabine and Docetaxel for Rescue Therapy in BCG Unresponsive Non-muscle Invasive Bladder Cancer Patients
An observational study of Bladder Cancer and BCG, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Bladder Cancer, BCG, Gemcitabine
- What is being tested?
- Intravesical Solution
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 9 Apr 2024to 9 Apr 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: a multi-center study within the scope of the Turkish Urooncology Association
Who may be able to join
- BCG refractory/relapsed/unresponsive or intolerant Who do not want or are not suitable for radical cystectomy
Who cannot join
- BCG naive A history of multiple cancers Having a radical cystectomy plan
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Dokuz Eylul University Faculty of Medicine Department of Urology
Izmir, Other (Non U.s.), 35330
Muhammed Selcuk Ozer, Medical Doctor, +905543078941, mseljukozer@gmail.com
Ozan Bozkurt, Professor, drozanbozkurt@gmail.com
About this study
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
- Being tested
- Intravesical Solution
- Keywords
- bladder cancer, BCG, Intravesical Instillation, Gemcitabine, Docetaxel
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravesical SolutionDrug
Also called Intravesical gemcitabin and docetaxel
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 group | Role | What they receive |
|---|---|---|
| Patients with BCG unresponsiveness and receiving intravesical gemcitabine doxetaxel | Not described Receives: Drug: Intravesical Solution | |
| Patients with BCG unresponsiveness and radical cystectomy performed | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate
the recurrence rate after intravesical chemotherapy will be calculated
Measured: 5 years
Progression rate
the progression rate after intravesical chemotherapy will be calculated
Measured: 5 years
Adverse effects of intravesical chemotherapy
the patients' data will be retrospectively analyzed to investigate the side effects of intravesical chemotherapy
Measured: 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
Measured: 5 years
Secondary outcomes (1)
treatment change
patient transitions from intravesical chemotherapy to other treatment options will be calculated
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start9 Apr 2024 (estimated)
- Primary completion9 Apr 2026 (estimated)
- Study completion9 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammed Selcuk Ozer, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374914
- Sponsor's protocol ID
- TUO-UR-23-05
- Status last verified
- Apr 2024
- First submitted
- 16 Apr 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sequential Intravesical Gemcitabine and Docetaxel for Rescue Therapy in BCG Unresponsive Non-muscle Invasive Bladder Cancer Patients
- ClinicalTrials.gov ID
- NCT06374914
- Acronym / sponsor ID
- TUO-UR-23-05
- Conditions
- Bladder Cancer, BCG, Gemcitabine, Docetaxel, Intravesical Instillation
- Keywords
- bladder cancer, BCG, Intravesical Instillation, Gemcitabine, Docetaxel
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 9 Apr 2024 (estimated)
- Primary completion
- 9 Apr 2026 (estimated)
- Study completion
- 9 Apr 2026 (estimated)
- First posted
- 19 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with BCG unresponsiveness and receiving intravesical gemcitabine doxetaxel | – | Drug: Intravesical Solution |
| Patients with BCG unresponsiveness and radical cystectomy performed | – | – |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- a multi-center study within the scope of the Turkish Urooncology Association
Key inclusion criteria (1 listed)
- BCG refractory/relapsed/unresponsive or intolerant Who do not want or are not suitable for radical cystectomy
Key exclusion criteria (1 listed)
- BCG naive A history of multiple cancers Having a radical cystectomy plan
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravesical SolutionAlso: Intravesical gemcitabin and docetaxelAlkalinization 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 | Drug | Patients with BCG unresponsiveness and receiving intravesical gemcitabine doxetaxel |
Primary outcome
Recurrence rate
Time frame: 5 years
the recurrence rate after intravesical chemotherapy will be calculated
Progression rate
Time frame: 5 years
the progression rate after intravesical chemotherapy will be calculated
Adverse effects of intravesical chemotherapy
Time frame: 5 years
the patients' data will be retrospectively analyzed to investigate the side effects of intravesical chemotherapy
Intravesical chemotherapy versus radical cystectomy
Time frame: 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
1 secondary outcome
treatment change
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
Related trials for Bladder Cancer
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
RecruitingPhase 3
A Clinical Trial of Sacituzumab Tirumotecan (Sac-TMT, MK-2870) and Pembrolizumab (MK-3475A) in Participants With Bladder Cancer (MK-2870-055)
Bladder Cancer
Active, not recruitingPhase 2/3
A Study of CTX-009 in Combination With Paclitaxel in Adult Patients With Unresectable Advanced, Metastatic or Recurrent Biliary Tract Cancers (COMPANION-002)
Biliary Tract Cancer, Cholangiocarcinoma
Recruiting
Effect of Cyclic Sighing Breathing Exercise on CRBD, Pain, and Sleep Quality in Patients Undergoing TUR
Transurethral Resection of Bladder Tumor, Transurethral Resection of the Prostate (TURP)
Recruiting
The Vanguard Study: Testing a New Way to Screen for Cancer
Bladder Carcinoma, Breast Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bladder Cancer and BCG, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Muhammed Selcuk Ozer, Medical Doctor (+905543078941 ext. +905543078941, mseljukozer@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate (time frame: 5 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.