2024-512683-53-00招募中4 期
RANDOMIZED CLINICAL TRIAL, OPEN, TO EVALUATE THE BLADDER INSTILLATION OF NEOADYUVANT CHEMOTHERAPY TO THE TRANSURETHAL RESECTION OF BLADDER FOR THE PREVENTION OF RECURRENCE OF NONMUSCLE-INVASIVE UROTHELIAL CARCINOMA
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 312
- 试验地点
- 4
- 主要终点
- Early recurrence rate of CVNMI.
研究概览
简要总结
Evaluation of the rate of early recurrences of CVNMI comparing intravesical instillation of neoadjuvant chemotherapy to TURBT with conventional TURBT without neoadjuvant chemotherapy.
研究设计
- 分配方式
- Randomized
- 主要目的
- Clinical trial Phase IV, randomised, open-label
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Patients of both sexes aged ≥ 18 years.
- •Patients with clinical and/or imaging evidence of CVNMI with indication for TURBT.
- •Patients with a history of stage CVNMI: Ta/T1, G1-G3, without concomitant CIS (Carcinoma in situ), provided they have a disease-free period of at least 6 months.
- •Karnofsky scale score > 70%.
- •Patients who agree to participate in the study by signing the informed consent.
- •Patients with tumors <3 cm.
排除标准
- •Tumors of solid or muscle invasive appearance on cystoscopy and/or preoperative imaging tests.
- •Pregnant patients.
- •Patients in whom it is foreseen that follow-up is not going to be possible for any reason.
- •Patients who for any reason should not be included in the study according to the evaluation of the research team.
- •Patients with a history of allergy to Mitomycin C, Epirubicin, Adriamycin, Cisplatin, Gemcitabine, Docetaxel.
- •Patients with severe urethral stricture or inability to catheterize the bladder for any other reason prior to TURBT.
- •Patients will be excluded from the clinical trial if, after TURBT, their pathological anatomy report shows a diagnosis other than papillary type IMIBC (CIS only, benign lesions, muscle invasive bladder carcinoma, etc.).
- •Patients with tumors ≥ 3 cm will not be included.
结局指标
主要结局
Early recurrence rate of CVNMI.
Early recurrence rate of CVNMI.
次要结局
- Adverse events of the drugs administered.
- Demographic characteristics (age, sex).
- Clinical characteristics (TNM classification, risk group, time of evolution, previous treatments received)
研究者
Luis Piñeiro
Scientific
Hospital Universitario La Paz
研究点 (4)
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