Evaluating the effectiveness of sequential therapy with Mitomycin-C and Gemcitabine for bladder cancer
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 BCG Therapy
This study is testing if a combination of two cancer drugs, Mitomycin-C and Gemcitabine, can help people with hard-to-treat bladder cancer stay cancer-free for a year after treatment.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 82 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | National Cancer Center, Korea Government |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Goyang-si) |
| Trial ID | NCT06388720 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety and effectiveness of sequential intravesical instillation of Mitomycin-C and Gemcitabine in patients with high-risk non-muscle invasive bladder cancer who are unresponsive to BCG treatment. It is a Phase 2, multi-institutional, open-label study that will measure the one-year recurrence-free survival rate among participants. Secondary outcomes will include progression-free survival, cystectomy-free survival, cancer-specific survival, overall survival, and safety profiles. The study will involve patients who meet specific histological criteria and have undergone recent bladder examinations.
Who should consider this trial
Good fit: Ideal candidates for this study are patients over 20 years old with histologically confirmed high-risk non-muscle invasive bladder cancer who are BCG unresponsive.
Not a fit: Patients with muscle-invasive bladder cancer or those who are eligible for radical bladder resection may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for patients with high-risk non-muscle invasive bladder cancer who have not responded to standard BCG therapy.
How similar studies have performed: While this approach is being evaluated in this trial, previous studies have shown promise with similar sequential therapies in bladder cancer treatment.
Eligibility criteria
Show full inclusion / exclusion 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 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 (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.
Where this trial is running
Goyang-si
- National Cancer Center — Goyang-si, South Korea (Recruiting)
Study contacts
- Principal investigator: Ho Kyung Seo, MD — National Cancer Center, Korea
- Study coordinator: Ho Kyung Seo, MD
- Email: seohk@ncc.re.kr
- Phone: 82-31-920-1678
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.