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Recruiting NCT06388720

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

Phase II Interventional Bladder Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mitomycin-C, gemcitabine.
Who it may be relevant to
Registry conditions: Bladder Cancer. Basic parameters: from 20 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Study to Assess the Clinical Effectiveness and Safety of Intravesical Mitomycin-C and Gemcitabine Sequential Therapy in Patients With High Risk Non-muscle Invasive Bladder Cancer (NMIBC) Unresponsive to BCG Therapy

Overview

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.

Interventions

  • Drug Mitomycin-C
    Intravesical instillation of Mitomycin-c 40 mg in 20 ml as the first agent in sequential treatment.
  • Drug gemcitabine
    Intravesical instillation of Gemcitabine 2000 mg in 50 ml following Mitomycin-c administration.

Primary outcome measures

  • High risk Recurrent free survival in sequential treatment group. [Time frame: 1year]
Secondary outcome measures (5)
  • Progression free survival in sequential treatment group. [Time frame: 1year]
  • Cystectomy free survival in sequential treatment group. [Time frame: 1year]
  • cancer specific survival in sequential treatment group. [Time frame: 1year]
  • Overall survival in sequential treatment group. [Time frame: 1year]
  • Safety of sequential treatment. [Time frame: 2year]

Eligibility criteria

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.
  • 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.

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

South Korea · 1 center
  • National Cancer Center — Goyang-si

Identifiers

NCT: NCT06388720 · NCC2024-0026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗