Intravesical instillation of BCG strain RIVM versus TICE for prevention of recurrenec in patients with high-risk papillary superficial carcinomas of the urinary bladder. A randomised phase II clinical trial - BCG RIVM vs. BCG TICE in patients with high-risk superficial bladder cancer

medac GmbH0 个研究点目标入组 186 人开始时间: 2007年5月29日最近更新: 2012年3月19日

试验速览

暂无简介。

•- histologically confirmed superficial carcinoma of the urinary bladder (high risk tumour, defined as pTa G3, pT1 G2-3, or pTa/pT1 with concomitant Cis; first diagnosis or recurrence) as documented by the reference pathologist
•- complete resection of all visible lesions by two TUR’s performed under standard visible light conditions
•- age: 19 years and older
•- patient’s written informed consent
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•- general health status according to WHO score (ECOG) < 2
•- patients with lymph node metastasis or other metastasis
•- other current malignancies (not including basalioma)
•- immunosuppressed patients with congenital or acquired immune deficiencies (e.g. positive HIV serology, leukaemia, lymphoma, corticosteroidal therapy)
•- prior BCG treatment
•- active tuberculosis
•- history of radiotherapy of the bladder
•- isolated Cis
•- residual urine > 50 ml
•- prosthetic valve
•- vascular prosthesis
•- gross haematuria
•- evidence of urinary infection
•- pregnancy (planned or existent) / lactation
•- simultaneous participation in other clinical trials
•- patients suffering from mental disorders

发起方