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
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- High risk Recurrent free survival in sequential treatment group.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Intervention group
Intravesical sequential treatment of Mitomycin-c 40mg/20ml and Gemcitabine 2000mg/50ml
干预措施: Mitomycin-C (Drug)
Intervention group
Intravesical sequential treatment of Mitomycin-c 40mg/20ml and Gemcitabine 2000mg/50ml
干预措施: gemcitabine (Drug)
结局指标
主要结局
High risk Recurrent free survival in sequential treatment group.
时间窗: 1year
Time from initial TURBT\* to first histologically confirmed recurrence of high-risk NMIBC or disease progression (per PFS definition), whichever occurs first.
次要结局
- Progression free survival in sequential treatment group.(1year)
- Overall survival in sequential treatment group.(1year)
- Safety of sequential treatment.(2year)
- Cystectomy free survival in sequential treatment group.(1year)
- cancer specific survival in sequential treatment group.(1year)
研究者
Ho Kyung Seo
Primary Investigator
National Cancer Center, Korea