KCT0009491
Not Yet Recruiting
N/A
A study to assess the clinical effectiveness and safety of intravesical mitomycin-C and gemcitabine sequential therapy in patients with high risk non-muscle invasive bladder cancer (NMIBC) unresponsive to Bacillus Calmette-Guerin (BCG) Therapy: Prospective, multicenter, open-label trial
ational Cancer Center0 sites82 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ational Cancer Center
- Enrollment
- 82
- Status
- Not Yet Recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. a patient over the age of 20
- •2\. Patients who are willing and able to complete a written test subject consent/approval for this examination.
- •3\. Patients with histological confirmation of high\-risk non\-muscle infiltration (T1, high\-grade Ta and/or CIS) bladder transition cell cancer. However, according to the definition of EAU guidelines high\-risk NMIBC, Ta, low grade, and multiple recurrences of more than 3 cm are included.
- •4\. 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 BCG:
- •? Appropriate BCG treatment must include.
- •\-Inductive treatment process (appropriate inductive treatment) with BCG administered at least 5 times; and
- •\-\- Maintain BCG at least twice within 9 months of proper induction treatment
- •? High\-risk NMIBCs that do not respond to BCG are defined as follows.
- •\- In spite of proper induction treatment, the stage deteriorated at the third month (e.g. from Ta to T1, or from CIS to T1\)
- •\- High risk NMIBC persists at 6 months (±4 weeks) after appropriate BCG treatment
Exclusion Criteria
- •1\.Patient diagnosed with muscle\-invasive bladder cancer at TURBT
- •2\.If upper urinary tract urothelial cancer is accompanied by imaging
- •3\.If the imaging indicates extravesical involvement (cT3\)
- •4\.Imaging shows lymph node metastasis (short\-axis 15mm or more) or distant metastasis
- •5\.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, paraganglioma, melanoma, lymphoma)
- •6\.In the case of receiving systemic cytotoxic chemotherapy for other cancers within 3 years
- •7\.If patient have a history of pelvic radiation therapy for other cancers within 3 years
- •8\.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
- •9\.If patient has a history of allergy to mitomycin\-c or gemcitabine
- •10\.Cystoscopy shows a tumor in the prostate urethra
Outcomes
Primary Outcomes
Not specified
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