To determine the Efficacy and Safety of Intravesical Chemotherapy (Gemcitabine + Mitomycin C) compared with Immunotherapy (BCG) in Reducing Progression and Recurrence Among Patients with High Grade Non Muscle Invasive Bladder Cancer Post TURBT: A RCT
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 74
- 试验地点
- 1
- 主要终点
- Comparative study between Intravesical Chemotherapy and Immunotherapy in reducing Progression and Recurrence among patients with high grade Non Muscle Invasive Bladder Cancer
研究概览
简要总结
The trial involves determining the efficacy and safety of Intravesical Chemotherapy (Gemcitabine+Mitomycin C) compared with Immunotherapy (BCG) in Reducing Progression and Recurrence among patients with High grade Non Muscle Invasive Bladder Cancer. Intravesical Therapy is to be followed after patients have undergone TransUrethral Resection of Bladder Tumour and diagnosis is pathologically confirmed.
Patients are to kept in follow up with Check Cystoscopy every 3rd month to check for recurrence and/or progression.
Randomization is to be done in an open label type, parallel arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Confirmed Pathology Report of Ca-Bladder (Non Muscle Invasive Bladder Cancer) -Available for whole duration of study -Absence of Any Concomitant Upper tract Urothelial Cancer.
排除标准
- •Presence of Lymphovascular Space Invasion or micropapillary disease -Patients receiving systemic therapy for Ca Bladder -Patient receiving current or prior External Beam RadioTherapy (EBRT) within 5 years -Pregnant or Lactating Females or refusing for contraception -Patients with symptomatic UTI or Cystitis -Patients with Metastatic bladder cancer -History of Malignancy of any other organ system within 5 years -Patient who cannot hold instillation for more than 1 hour (Overactive Bladder) -patient who cannot tolerate Intravesical dosing or surgical treatment Are hereby, excluded from the study.
结局指标
主要结局
Comparative study between Intravesical Chemotherapy and Immunotherapy in reducing Progression and Recurrence among patients with high grade Non Muscle Invasive Bladder Cancer
时间窗: Subjects will be assessed every 3 months with check cystourethroscopy.
次要结局
- To check for remission of Bladder tumour post commencement of intravesical therapy(Radiological investigations (USG KUB) alongwith check Cystoscopy to be done every third month)
研究者
Shatakshi Mishra
Lala Lajpat Rai-Hallet Hospital, GSVM Medical College