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

NCT ID: NCT06388720

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-19
• Study Completion Date: 2027-12-31

Brief 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.

Conditions

Bladder Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

Intravesical sequential treatment of Mitomycin-c 40mg/20ml and Gemcitabine 2000mg/50ml

Group Type: EXPERIMENTAL

Mitomycin-C

Intervention Type: DRUG

Intravesical instillation of Mitomycin-c 40 mg in 20 ml as the first agent in sequential treatment.

gemcitabine

Intervention Type: DRUG

Intravesical instillation of Gemcitabine 2000 mg in 50 ml following Mitomycin-c administration.

Interventions

Mitomycin-C

Intravesical instillation of Mitomycin-c 40 mg in 20 ml as the first agent in sequential treatment.

Intervention Type: DRUG

gemcitabine

Intravesical instillation of Gemcitabine 2000 mg in 50 ml following Mitomycin-c administration.

Intervention Type: DRUG

Other Intervention Names

Sequential treatment group

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Center, Korea

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ho Kyung Seo

Primary Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ho Kyung Seo, MD

Role: PRINCIPAL_INVESTIGATOR

National Cancer Center, Korea

Locations

National Cancer Center

Goyang-si, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Ho Kyung Seo, MD

Role: CONTACT

seohk@ncc.re.kr

82-31-920-1678

Eui Hyun Jung, Ph.D

Role: CONTACT

jeh0315@ncc.re.kr

82-31-920-2451

Facility Contacts

Ho Kyung Seo

Role: primary

seohk@ncc.re.kr

82-31-920-1678

Other Identifiers

NCC2024-0026

Identifier Type: -

Identifier Source: org_study_id