Prospective randomised study of the impact of preoperative administration of mitomycin-C by electromotive drug administration (EMDA) in patients with non-muscle invasive urothelial carcinoma
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 228
- 试验地点
- 2
- 主要终点
- Recurrence free survival
研究概览
简要总结
Determine the impact of electromotive drug administration (EMDA) with mitomycin C (MMC) before transurethral resection (TUR) in patients with primary and recurrent low-grade non-muscle invasive bladder tumors and evaluate the recurrence rate (understanding recurrence as the appearance of a new non-muscle invasive bladder tumor with staging T grade equal to or lower than the baseline tumor) and/or progression (understanding progression as the appearance of a new bladder tumor with staging T grade higher than the baseline tumor) and the time to first event in patients with NMIBC who receive MMC+EMDA before TUR compared to passive diffusion MMC instillation after TUR.
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 with suspected urothelial cell carcinoma Ta or T1 based on cystoscopy and/or ultrasound.
- •Primary papillary tumor
- •Recurrent low-grade single or multiple tumors.
- •Patients with preserved renal function (serum creatinine < 1.12 mg/dl) and normal liver function (gamma-glutamyl transpeptidase ≤ 51 U/L, alanine aminotransferase ≤ 50 U/L, and total bilirubin ≤ 22 μmol/L).
- •Documented and signed authorization to participate in clinica trial
排除标准
- •Patients with histology different from urothelial carcinoma after the pathological analysis of the surgical specimen.
- •History of untreated urinary tract infection.
- •Severe systemic infection.
- •Treatment with radiotherapy or chemotherapy.
- •Treatment with immunosuppressants.
- •Patients with a pacemaker or implantable cardioverter-defibrillator (ICD).
- •Other malignancies within the 5 years prior to study inclusion (except for effectively treated skin cancer or localized cervical cancer).
- •Patients with bladder cancer staged ≥ T
- •Patients with synchronous upper tract urothelial carcinoma (UTUC)
- •Allergy to Mitomycin-C.
- •Patients who, in the investigator's opinion, are unable to complete the study questionnaires or attend follow-up visits.
- •Patients with recurrent high-grade tumor.
- •Patients with recurrent CIS.
- •Reduced bladder capacity (less than 200 cc)
- •History of high-grade bladder tumor or CIS.
结局指标
主要结局
Recurrence free survival
Recurrence free survival
Progresion free survival
Progresion free survival
次要结局
- Total cases of adverse effects by group
- Therapeutic completion rate by group
- Impact of recurrence free survival and progresion free survival depending on inflammatory response parameters
研究者
Guillem Abad Carratalá
Scientific
Fundacion Para El Fomento De La Investigacion Sanitaria Y Biomedica De La Comunitat Valenciana