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

NCT06388720 | Recruiting Phase 2

• 1 other identifier: NCC2024-0026
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Bladder Cancer

Keywords

high risks non-muscle invasive bladder cancer; Sequential treatment; Intravesical treatment; Mitomycin-c; Gemcitanine

Outcome Measures

Primary Outcomes (1)

• High risk Recurrent free survival in sequential treatment group.

  Time from initial TURBT\* to first histologically confirmed recurrence of high-risk NMIBC or disease progression (per PFS definition), whichever occurs first.

  1year

Secondary Outcomes (5)

• Progression free survival in sequential treatment group.

  1year

• Cystectomy free survival in sequential treatment group.

  1year

• cancer specific survival in sequential treatment group.

  1year

• Overall survival in sequential treatment group.

  1year

• Safety of sequential treatment.

  2year

Study Arms (1)

Intervention group

EXPERIMENTAL

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

Drug: Mitomycin-C; Drug: gemcitabine

Interventions

Mitomycin-C DRUG

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

Also known as: Sequential treatment group

Intervention group

gemcitabine DRUG

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

Intervention group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• a patient over the age of 20
• Patients who are willing and able to complete a written test subject consent/approval for this examination.
• 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.
• 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
• Patients who are not eligible for a radical bladder resection or who have refused surgery.
• Patient who are not being pregnant or breast feeding until the study period.

You may not qualify if:

• Patient diagnosed with muscle-invasive bladder cancer at TURBT
• If upper urinary tract urothelial cancer is accompanied by imaging
• If the imaging indicates extravesical involvement (cT3)
• Imaging shows lymph node metastasis (short-axis 15mm or more) or distant metastasis
• 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)
• In the case of receiving systemic cytotoxic chemotherapy for other cancers within 3 years
• If patient have a history of pelvic radiation therapy for other cancers within 3 years
• 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
• If patient has a history of allergy to mitomycin-c or gemcitabine
• Cystoscopy shows a tumor in the prostate urethra
• 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
• After post-cystoscopy/TURBT, the patient received intravesical chemotherapy prior to the start of trial treatment
• Thrombocytopenia, coagulopathy or bleeding tendency patient.
• Pregnant or breast-feeding women
• If patient treated yellow fever vaccine or phenytoin

Sponsors & Collaborators

• Korea University Anam Hospital: collaborator
• Samsung Medical Center: collaborator
• Severance Hospital: collaborator
• Seoul St. Mary's Hospital: collaborator
• Pusan National University Hospital: collaborator
• Seoul National University Bundang Hospital: collaborator
• Chonnam National University Hospital: collaborator
• National Cancer Center, Korea: lead

Study Sites (1)

National Cancer Center

Goyang-si, South Korea

RECRUITING

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

Mitomycin; Gemcitabine

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines

Study Officials

• Ho Kyung Seo, MD

  National Cancer Center, Korea

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ho Kyung Seo, MD

CONTACT

82-31-920-1678; seohk@ncc.re.kr

Eui Hyun Jung, Ph.D

CONTACT

82-31-920-2451; jeh0315@ncc.re.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Primary Investigator

Study Record Dates

• First Submitted: April 24, 2024
• First Posted: April 29, 2024
• Study Start: November 19, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: May 29, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)