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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• High risk Recurrent free survival in sequential treatment group. [Срок оценки: 1year]

Вторичные конечные точки (5)

• Progression free survival in sequential treatment group. [Срок оценки: 1year]
• Cystectomy free survival in sequential treatment group. [Срок оценки: 1year]
• cancer specific survival in sequential treatment group. [Срок оценки: 1year]
• Overall survival in sequential treatment group. [Срок оценки: 1year]
• Safety of sequential treatment. [Срок оценки: 2year]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

South Korea · 1 центр

• National Cancer Center — Goyang-si

Идентификаторы

NCT: NCT06388720 · NCC2024-0026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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