Safety and Efficacy of Scheduled Intravesical Gemcitabine Versus Intravesical BCG for Intermediate and High Risk Non Muscle Invasive Bladder Cancer: A Prospective, Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Recurrence free survival (RFS)
研究概览
简要总结
About 40%-80% of NMIBC recur within 6-12 months when managed with TURBT alone, and 10%-25% of the patient's progress to muscle invasive disease. Intravesical therapy enables delivery of high local concentrations of a therapeutic agent within the bladder, which could potentially destroy viable tumor cells that remain following TURBT
详细描述
Bladder cancer (BC) is the tenth most commonly diagnosed cancer worldwide. Approximately 75% of patients with BC present with disease confined to the mucosa (stage Ta or CIS) or submucosa (stage T1); for younger patients (<40 year) this Percentage is even higher (Babjuk et al., 2022).
About 40%-80% of NMIBC recur within 6-12 months when managed with TURBT alone, and 10%-25% of the patient's progress to muscle invasive disease. Intravesical therapy enables delivery of high local concentrations of a therapeutic agent within the bladder, which could potentially destroy viable tumor cells that remain following TURBT (Ye Z, et al., 2018 and Daneshmand et al., 2022).
The Intravesical BCG injection can reduce the recurrence rate by about 30-40%. For intravesical therapy, chemotherapy drugs such as mitomycin C, gemcitabine, and epirubicin can be used post-TURBT, which is a good alternative treatment for BCG or a second-line treatment (Ansari et al., 2022).
The BCG vaccine was firstly developed by Albert Calmette over a hundred years ago. Its effect on bladder cancer was proposed by Dr. Alvaro Morales about forty years ago. In 1990, BCG was approved by the Food and Drug Administration (FDA) for the treatment of NMIBC and then became the first-line drug in NMIBC up to now (Ansari et al., 2022).
Due to worldwide shortage of BCG, there is a clinical need to develop novel intravesical agents and application forms in order to improve the oncological outcomes in non-muscle invasive bladder cancer (NMIBC). Gemcitabine has been investigated in various clinical trials. It has proven to be superior to BCG re-challenge and mitomycin (MMC) in BCG-unresponsive high-risk NMIBC (Gakis, 2022).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The study will include moderate and high risk patients with NMIBC. Very high risk NMIBC patients, whom refusing radical cystectomy.
排除标准
- •Active UTI.
- •Suspected bladder perforation.
- •Hematuria.
- •Any contraindications for gemcitabin therapy; hypersenstivity, pregnancy, an infection, hemolytic uremic syndrome, , anemia, decreased blood platelets, low levels of a type of white blood cell called neutrophils.
- •Patients whom previously received any inravesical therapy (e.g. prior BCG).
研究组 & 干预措施
Inravesical BCG
Intravsical induction and maintenance BCG injections.
干预措施: BCG (Drug)
Inravesical Gemcitabin
Intravsical induction and maintenance gemcitabin injections.
干预措施: Gemcitabine (Drug)
结局指标
主要结局
Recurrence free survival (RFS)
时间窗: 2 YEARS
time from the commencement of induction treatment to recurrence. All recurrences will be confirmed by cystoscopic guided biopsy and histology.
Progression free survival (PFS)
时间窗: 2 YEARS
progression in the initial tumour staging during follow-up cystoscopy. All progressions will be confirmed by histopathologic evaluation.
次要结局
- Side effects of intravesical gemcitabine injection.(2 YEARS)
- Side effects of intravesical BCG injection.(2 YEARS)
研究者
Mohamed Fawzy Abd Elfattah Salman
Director
Al-Azhar University