A Randomized Prospective Trial Comparing Bacillus Calmette-Guerin (BCG) RIVM and Russian Strains in Non-Muscle Invasive Bladder Cancer: Efficacy and Side Effects
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- progression free survival
研究概览
简要总结
The goal of this clinical trial is to compare the efficacy and safety of two Bacillus Calmette-Guérin (BCG) substrains (RIVM and Russian) in the treatment of intermediate- and high-risk non-muscle-invasive bladder cancer (NMIBC) in adult patients.
The main questions it aims to answer are:
- Is there a significant difference in recurrence-free survival (RFS) between the BCG RIVM and BCG Russian substrains?
- Is there a significant difference in progression-free survival (PFS) between the two substrains?
- Are there notable differences in the incidence of treatment-related adverse events between the strains? Researchers will compare patients treated with BCG RIVM to patients treated with BCG Russian to determine whether one substrain offers superior clinical outcomes in terms of recurrence, progression, and adverse events.
Participants will:
Undergo transurethral resection of bladder tumor (TURBT) prior to initiating therapy.
Be randomly assigned to receive either BCG RIVM or BCG Russian intravesical therapy.
Receive an induction course of six weekly instillations of the assigned BCG substrain.
Receive maintenance therapy at regular intervals (3, 6, 12, 18, 24, 30, and 36 months) based on risk classification.
Undergo regular follow-up with cystoscopy and urine cytology to assess recurrence, progression, and adverse events.
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
- •age ≥18 years,
- •histopathologically confirmed NMIBC (stages Ta, T1, or CIS),
- •classification as intermediate, high, or very high risk (who either refused or were not suitable candidates for radical cystectomy),
- •no prior BCG therapy,
- •no evidence of upper urinary tract carcinoma or distant metastases and
- •a minimum follow-up period of 12 months.
排除标准
- •patients who did not receive adequate BCG therapy (defined as receiving fewer than 5 of the 6 induction doses or fewer than 2 of the 3 maintenance doses),
- •patients with a follow-up period of less than 12 months and
- •patients who received multiple BCG strains during the follow-up period.
研究组 & 干预措施
Group 1 which received BCG RIVM
following transurethral resection of bladder tumor (TURBT), patients in Group 1 received BCG RIVM.
干预措施: Bacillus Calmette-Guerin (BCG) (Drug)
Group 2 which received BCG RUSSIAN
following transurethral resection of bladder tumor (TURBT), patients in Group 2 received BCG RUSSIAN.
干预措施: Bacillus Calmette-Guerin (BCG) (Drug)
结局指标
主要结局
progression free survival
时间窗: Through study completion, up to 4 years
recurrence free survival
时间窗: Through study completion, up to 4 years
次要结局
- side effects of the treatment(At each BCG instillation and follow-up visit, up to 4 years)
研究者
Khaled Obaid
Principal Investigator , Urologist
Ankara University