Optimal Adjuvant Intravesical Therapy for Intermediate Risk Non Muscle Invasive Bladder Cancer: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Tumor Progression rate
研究概览
简要总结
The objective of this prospective, single-center randomized controlled trial is to identify the optimal adjuvant intravesical therapy in patients with intermediate risk (IR) non muscle invasive bladder cancer by comparing two commonly utilized intravesical regimens; intravesical immunotherapy (BCG) and intravesical chemotherapy.
详细描述
Bladder cancer (BC) represents a frequent urologic malignancy, and is mainly diagnosed as non-muscle invasive, At presentation, approximately 30% of patients have muscle-invasive BC (clinical T2 or higher) .
Both the natural history of non-muscle-invasive bladder cancer (NMIBC) and its treatment strategies are highly variable. Although some patients never experience disease recurrence, others experience disease progression and eventually die of their disease .
In the absence of intravesical treatment, a patient with non-muscle-invasive BC has a 47% probability of disease recurrence within 5 years of diagnosis and a 9% probability of progression to muscle-invasive disease .
Low-, intermediate- and high-risk categories have been defined to help guide the treatment of patients with NMIBC (Ta, T1, and CIS). Treatment of NMIBC is now relatively well-defined for high-risk and low-risk disease presentation, and awaits further refinement through improvements in therapeutic options .
Solitary low-grade tumors, especially smaller lesions (3 cm or less), respond best to resection and immediate instillation of intravesical agents, whereas higher risk lesions, such as carcinoma in situ and high-grade T1 stage disease, have demonstrated good response to BCG when given on a schedule of induction (an initial 6-week course) and maintenance (3-weekly courses every 6 months for 3 years) .
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (aged >18 years)
- •Patients with primary or recurrent papillary NMIBC.
- •Complete TURBT.
- •Patients with IR NMIBC confirmed by histopathology.
排除标准
- •Inability to give informed consent.
- •Patients with history of previous radiotherapy or systemic chemotherapy.
- •Patients suffering from immuno-deficiency or other malignancies.
- •Patients with history of hypersensitivity reaction to BCG or epirubicin.
- •Examination under anesthesia (EUA) reveals palpable bladder mass.
- •Patients with low or high risk NMIBC by histopathology
研究组 & 干预措施
Intravesical immunotherapy (BCG) group
干预措施: Intravesical Bcg (Drug)
Intravesical chemotherapy (Epirubicin) group
干预措施: Intravesical chemotherapy (epirubicin) (Drug)
结局指标
主要结局
Tumor Progression rate
时间窗: 2 years
Number of patient who will develop Progression rate during follow up
Tumor recurrence rate
时间窗: 2 years
Number of patient who will develop Recurrence rate during follow up
次要结局
- Side effects from intravesical treatments(2 years)
研究者
Amr Abdel-Lateif El-Sawy
Lecturer of Urology
Mansoura University
