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Tests treatment safety and results for Bladder Cancer
Official title The Clinical Effectiveness and Safety of Intravesical Mitomycin-C and Gemcitabine Sequential Therapy
ClinicalTrials.gov ID: NCT06388720
What this study is testing
What is Mitomycin-C?
Mitomycin-C is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for bladder cancer.
Also referred to as Sequential treatment group.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The aim of this study is to evaluate the effectiveness and safety of mitomycin-c and gemcitabine sequential instillation in BCG unresponsive high risk non-muscle invasive bladder cancer patients.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 20 and older
You may be able to join if
- a patient over the age of 20
- Patients who are willing and able to complete a written test subject consent/approval for this examination.
- Histologically confirmed high-risk NMIBC (according to AUA guidelines; High-grade T1 disease, any recurrent high-grade Ta, high-grade Ta \>3 cm...
- The most recent bladder examination/TURBT must be performed within 8 weeks before the initial administration of the trial treatment. Patients with...
- Patients who are not eligible for a radical bladder resection or who have refused surgery.
You likely can't join if
- Patient diagnosed with muscle-invasive bladder cancer at TURBT
- If upper urinary tract urothelial cancer is accompanied by imaging
- If the imaging indicates extravesical involvement (cT3)
- Imaging shows lymph node metastasis (short-axis 15mm or more) or distant metastasis
- In a biopsy, non-transitional cell histology is dominant, or only non-transitional cell tissue is present (primary squamous cell carcinoma, primary...
- In the case of receiving systemic cytotoxic chemotherapy for other cancers within 3 years
See the full eligibility criteria
- a patient over the age of 20
- Patients who are willing and able to complete a written test subject consent/approval for this examination.
- Histologically confirmed high-risk NMIBC (according to AUA guidelines; High-grade T1 disease, any recurrent high-grade Ta, high-grade Ta \>3 cm, high-grade Ta that is multifocal, any carcinoma in situ, any BCG failure...
- The most recent bladder examination/TURBT must be performed within 8 weeks before the initial administration of the trial treatment. Patients with high risk NMIBC who received proper BCG treatment but did not respond to...
- Patients who are not eligible for a radical bladder resection or who have refused surgery.
- Patient who are not being pregnant or breast feeding until the study period.
- Patient diagnosed with muscle-invasive bladder cancer at TURBT
- If upper urinary tract urothelial cancer is accompanied by imaging
- If the imaging indicates extravesical involvement (cT3)
- Imaging shows lymph node metastasis (short-axis 15mm or more) or distant metastasis
- In a biopsy, non-transitional cell histology is dominant, or only non-transitional cell tissue is present (primary squamous cell carcinoma, primary adenocarcinoma, small cell carcinoma, sarcoma, carcinosarcoma...
- In the case of receiving systemic cytotoxic chemotherapy for other cancers within 3 years
- If patient have a history of pelvic radiation therapy for other cancers within 3 years
- If patient have a history of receiving Mitomycin-c or gemcitabine in the bladder within 3 years. The exception is cases used for the purpose of injection therapy of anticancer drugs in the early bladder cancer
- If patient has a history of allergy to mitomycin-c or gemcitabine
- Cystoscopy shows a tumor in the prostate urethra
- Patients who have participated in studies using clinical trial drugs and are currently receiving clinical trial drugs or who have used clinical trial drugs or clinical trial medical devices within 4 weeks prior to the...
- After post-cystoscopy/TURBT, the patient received intravesical chemotherapy prior to the start of trial treatment
- Thrombocytopenia, coagulopathy or bleeding tendency patient.
- Pregnant or breast-feeding women
- If patient treated yellow fever vaccine or phenytoin
- Dysfunction of liver or kidney (GFP≤30)
- If patient undergo severe myelosuppression
- If patient complicated severe infection
- If patient definitely diagnosed interstitial lung disease or lung fibrosis by chest X-ray.
- If patient conduct chest radiotherapy.
The study team makes the final eligibility decision.
Where it's taking place
- Goyang-si, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 20 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Goyang-si, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.