Treatment of High-risk Non-muscle Invasive Bladder Cancer With IMUNO BGC Moreau RJ as Prophylaxis of Recurrence and Progression.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 306
- 试验地点
- 15
- 主要终点
- progression-free survival
研究概览
简要总结
Bladder cancer is the fourth reason of neoplasia in our environment, there are 25 new cases diagnosed per 100,000 inhabitants each year. To decrease the recurrence there are two standardized treatments: Mitomycin as chemotherapy drug and BCG *Bacile Calmette-Guérin" as immunotherapy drug.
BCG Moreau strain is not authorized by AEMPS, it was developed in Brazil and this country has extensive experience in treatment of non-muscle invasive bladder cancer with BCG Moreau, also BCG Moreau Rio de Janeiro make same immunological reaction as TICE, but with less adverse events. Thus, BCG Moreau RJ treatment could be used more time than TICE with the same dose, keeping immunologic status and better prophylaxis of recurrence or progression results for the patient.
Each patient will be instillated via transurethral each time with 80 mg of IMUNO BCG Moreau RJ. There are 15 instillations during the clinical trial, 6 instillations on induction phase and 9 will be performed during maintaince phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signature of the informed consent before any activity related to the study, including the necessary evaluations for the selection.
- •Age between 18 and 80 years at the time of signing the informed consent.
- •Urothelial tumor.
- •High risk non-muscle invasive bladder tumor (defined as Ta-T1 and GIIb or GIII) diagnosed de novo or relapsed with or without associated in situ carcinoma. or carcinoma in situ isolated without visible tumor.
- •Patient with risk of recurrence or progression greater than or equal to 10 points, according to CUETO tables.
排除标准
- •No muscle layer in pathological examination piece's.
- •Non-urothelial tumor.
- •Active cancer in any other location.
- •Diagnosis of any other pathology that in the opinion of the researcher may increase the risk of the subject or reduce the chances of obtaining satisfactory data to achieve the objectives of the study, including the consumption of alcohol or any other drug.
- •Administration of BCG in the last year before signing the informed consent.
- •BCG instillation contraindication during more than 15 days for any cause such as low bladder capacity, urinary infection, hematuria, etc.
- •Impossibility of performing a second transurethral resection (ReRTU) between 4 and 8 weeks after the first.
- •Inability to start treatment within the first 4 weeks after the second transurethral resection (ReRTU).
- •Participation in another clinical study where they received a research drug in the 6 months prior to signing the informed consent.
- •Woman considered potentially fertile. Following the Clinical Trial Facilitation Group (CTFG) recommendations, a woman is considered childbearing potential (WOCBP), following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
- •Patients with difficulties to perform the follow-up visits established in the protocol.
研究组 & 干预措施
treated with IMUNO BCG Moreau RJ adjuvant.
干预措施: Instillation of IMUNO BCG Moreau RJ (Biological)
结局指标
主要结局
progression-free survival
时间窗: 24 months
The primary objective is to assessment the progression-free survival of patients diagnosed with high-risk non-muscle invasive bladder tumors treated with IMUNO BCG Moreau RJ adjuvant.
次要结局
- Assessment of adverse reactions(24 months)
- Disease-free survival.(24 months)
- Assessment of the quality of life(24 months)
- Assessment of the dropout rate due to toxicity(24 months)