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

Not Applicable

Conditions: Neoplasms

Registration Number: KCT0009491

Lead Sponsor: ational Cancer Center

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot yet recruiting

Sex: All

Target Recruitment: 82

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
- High-risk NMIBC relapses within 6 months of most recent BCG administration despite appropriate BCG treatment
5. Patients who are not eligible for a radical bladder resection or who have refused surgery.
? Non-conformity cases for radical bladder removal include, but are not limited to, the following:
- Cardiovascular disease (e.g., recent acute coronary syndrome, arrhythmia, heart failure)
- Chronic obstructive pulmonary disease that will prevent safe operation at the discretion of the surgeon
- Poor overall activity (e.g. ECOG >2)
- Previous major abdomen that will prevent safe operation at the discretion of the surgeon and the history of pelvic surgery
6. Patient who are not being pregnant or breast feeding until the study period.

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
11.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 date of initial treatment
12.After post-cystoscopy/TURBT, the patient received intravesical chemotherapy prior to the start of trial treatment
13.Thrombocytopenia, coagulopathy or bleeding tendency patient.
14.Pregnant or breast-feeding women
15.If patient treated yellow fever vaccine or phenytoin
16.Dysfunction of liver or kidney (GFP=30)
17.If patient undergo severe myelosuppression
18.If patient complicated severe infection
19.If patient definitely diagnosed interstitial lung disease or lung fibrosis by chest X-ray.
20.If patient conduct chest radiotherapy.