CHEMO-RESECTION WITH HYPERTHERMIC INTRAVESICAL INSTILLATION (HIVEC-R) VS STANDARD TREATMENT IN PATIENTS WITH NMIBT: COMPARATIVE, PROSPECTIVE AND RANDOMIZED STUDY OF EFFICACY AND TOLERABILITY - HIVEC - R

DR. ALEJANDRO SOUSA ESCANDÓ0 个研究点开始时间: 2015年3月3日最近更新: 2015年8月24日

适应症

试验速览

暂无简介。

•- Patients with NMIBC for which TURB is indicated except those recurrent with previous T1G3 or CIS in the last 12 moths and positive cytology
•- WHO scale 0, 1, 2, 3
•- Age ? 18 yrs
•- Normal kidneys and ureters
•- Pre-treatment haematology and biochemistry values within
•acceptable limits
•- Negative pregnancy test for women of child-bearing potential
•- Written informed consent (IC)
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 34
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 34

•- Patient with solid tumor and muscle infiltrating aspect or with associated plane lesions suspicious for CIS
•- Recurrent patients with previous T1G3 or CIS in the last 12 months and positive cytology
•- Patients with hypersensitivity or allergy to MMC
•- History of limited vesical capacity (<200cc)
•- UCC involving the prostatic urethra or upper urinary tract
•- Pregnant or lactating women or women of childbearing potential
•unwilling or unable to use adequate non-hormonal contraception
•- Other malignancy within the past five years, except: nonmelanomatous
•skin cancer cured by excision, adequately treated
•carcinoma in situ of the cervix or DCIS/LCIS of the breast or prostate cancer.
•- Patients with tumours histologically different tan transitional cell
•- Patients that for any reason should receive concurrent chemotherapy

发起方

DR. ALEJANDRO SOUSA ESCANDÓ