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临床试验/NCT05146635
NCT05146635Unknown不适用

Optimal Adjuvant Intravesical Therapy for Intermediate Risk Non Muscle Invasive Bladder Cancer: A Randomized Controlled Trial

Mansoura University1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2021年12月1日最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

干预措施: Intravesical Bcg (Drug)

Intravesical chemotherapy (Epirubicin) group

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amr Abdel-Lateif El-Sawy

Lecturer of Urology

Mansoura University

研究点 (1)

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