Actively Recruiting
The Clinical Effectiveness and Safety of Intravesical Mitomycin-C and Gemcitabine Sequential Therapy
Led by National Cancer Center, Korea · Updated on 2026-04-13
82
Participants Needed
1
Research Sites
162 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The Clinical Effectiveness and Safety of Intravesical Mitomycin-C and Gemcitabine Sequential Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient is over 20 years old
- Patients willing and able to provide written informed consent
- Histologically confirmed high-risk non-muscle invasive bladder cancer (T1, high-grade Ta and/or CIS) including EAU-defined high-risk NMIBC
- Most recent bladder examination or TURBT within 8 weeks before initial treatment
- High-risk NMIBC patients unresponsive to proper BCG treatment
- Patients ineligible for radical bladder surgery or who have refused surgery
- Not pregnant or breastfeeding during the study period
You will not qualify if you...
- Muscle-invasive bladder cancer diagnosed at TURBT
- Presence of upper urinary tract urothelial cancer on imaging
- Imaging shows extravesical involvement (cT3)
- Imaging shows lymph node metastasis ≥15 mm or distant metastasis
- Non-transitional cell dominant histology or only non-transitional cancer types
- Systemic cytotoxic chemotherapy for other cancers within past 3 years
- History of pelvic radiation therapy for other cancers within past 3 years
- Mitomycin-c or gemcitabine bladder treatment within past 3 years (except early bladder cancer injection therapy)
- Allergy to mitomycin-c or gemcitabine
- Tumor detected in prostate urethra by cystoscopy
- Participation in clinical trials involving drugs or devices within 4 weeks prior to treatment
- Intravesical chemotherapy after cystoscopy/TURBT before trial treatment
- Thrombocytopenia, coagulopathy, or bleeding tendency
- Pregnant or breastfeeding women
- Recent treatment with yellow fever vaccine or phenytoin
- Liver or kidney dysfunction (GFP ≤30)
- Severe myelosuppression
- Severe infection
- Diagnosed interstitial lung disease or lung fibrosis by chest X-ray
- History of chest radiotherapy
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Cancer Center
Goyang-si, South Korea
Actively Recruiting
Research Team
H
Ho Kyung Seo, MD
CONTACT
E
Eui Hyun Jung, Ph.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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