AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

RecruitingPhase 2Ages 20 Years - anyAllNational Cancer Center, Korea
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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. 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 in high-grade patients, any variant histology, any lymphovascular invasion, and any high-grade prostatic urethral involvement) with prior BCG therapy. 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 5. Patients who are not eligible for a radical bladder resection or who have refused 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 (GFPโ‰ค30) 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.
๐Ÿ’Š

What it tests

  • Mitomycin-C
  • gemcitabine
๐Ÿ“

Where

1 site
National Cancer Center
Goyang-si, South Korea
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy