RecruitingPhase 2

The Clinical Effectiveness and Safety of Intravesical Mitomycin-C and Gemcitabine Sequential Therapy

South Korea82 participantsStarted 2024-11-19

Plain-language summary

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.

Who can participate

Age range20 Years

SexALL

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Inclusion 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.
✓. 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.
✓. 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
✓. 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.

Exclusion criteria

✕. 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, paraganglioma, melanoma, lymphoma)
✕. 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

What they're measuring

High risk Recurrent free survival in sequential treatment group.

Timeframe: 1year

Trial details

NCT IDNCT06388720

SponsorNational Cancer Center, Korea

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2027-12-31

Contact for this trial

Ho Kyung Seo, MD

82-31-920-1678 seohk@ncc.re.kr

View on ClinicalTrials.gov More Bladder Cancer trials