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

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

NCT ID: NCT06388720

Condition: Bladder Cancer

Conditions: Official terms:
Urinary Bladder Neoplasms
Gemcitabine
Mitomycins
Mitomycin

Conditions: Keywords:
high risks non-muscle invasive bladder cancer
Sequential treatment
Intravesical treatment
Mitomycin-c
Gemcitanine

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Mitomycin-c 40mg/20ml and Gemcitabine 2000mg/50ml
Description: Intravesical sequential treatment of Mitomycin-c 40mg/20ml and Gemcitabine 2000mg/50ml.
Arm group label: Intervention group

Other name: Sequential treatment group

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.

Detailed description: Phase 2 clinical, multi-institutional, open assignment prospective study Primary Outcome Measures: 1-year recurrence-free survival period in high-risk groups after sequential injection of Mitomycin-c 40 mg/20 ml and Gemcitabine 2000 mg/50 ml in non-muscle invasive bladder cancer patients in BCG-free high-risk groups. Secondary Outcome Measures: Progression Free Survival (PFS), Cystectomy free survival (CFS), Cancer specific survival (CSS), Overall survival (OS) and safety after Mitomycin-c 40mg/20ml and Gemcitabine 2000mg/50ml treatment in non-muscle invasive bladder cancer patients in BCG-free high-risk groups.

Criteria for eligibility:
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.

Gender: All

Minimum age: 20 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: National Cancer Center

Address:
City: Goyang-si
Country: Korea, Republic of

Status: Recruiting

Contact:
Last name: Ho Kyung Seo

Phone: 82-31-920-1678
Email: seohk@ncc.re.kr

Investigator:
Last name: Ho Kyung Seo, MD
Email: Principal Investigator

Investigator:
Last name: Eui Hyun Jung, Ph.D
Email: Sub-Investigator

Start date: April 30, 2024

Completion date: December 31, 2027

Lead sponsor:
Agency: National Cancer Center, Korea
Agency class: Other

Source: National Cancer Center, Korea

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06388720