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

National Cancer Center (NCC)

Status and phase

Enrolling

Phase 2

Conditions

Bladder Cancer

Treatments

Drug: gemcitabine

Drug: Mitomycin-C

Study type

Interventional

Funder types

Other

Identifiers

NCT06388720

NCC2024-0026

Details and patient eligibility

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.

Full 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.

Enrollment

82 estimated patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

a patient over the age of 20
Patients who are willing and able to complete a written test subject consent/approval for this examination.
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.
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.

Exclusion criteria

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
Dysfunction of liver or kidney (GFP≤30)
If patient undergo severe myelosuppression
If patient complicated severe infection
If patient definitely diagnosed interstitial lung disease or lung fibrosis by chest X-ray.
If patient conduct chest radiotherapy.