A phase II randomised feasibility study of chemoresection and surgical management in low risk non muscle invasive bladder cancer. - CALIBER

The Institute of Cancer Research0 个研究点目标入组 89 人开始时间: 2014年8月12日最近更新: 2019年2月28日

试验速览

暂无简介。

•1.Written informed consent
•2.NMIBC recurrence following original diagnosis of low risk NMIBC (defined as Ta G1 or Ta G2 (Ta low grade) with a risk of recurrence score of =6 using EORTC risk tables).
•3.Histologically confirmed TCC at original diagnosis
•4.Aged 16 or over
•5.Satisfactory pre-treatment haematology values haemoglobin > 100 g/L and serum creatinine < 1.5xULN
•6.Negative pregnancy test for women of child-bearing potential
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 0
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 100
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 74

•1.Any history of: grade 3/high grade or =T1 transitional cell carcinoma, concomitant carcinoma in situ, more than 7 tumours at one diagnosis or more than 1 recurrence per year since initial diagnosis or in the past five years, whichever is shorter
•2.Any history of histologically confirmed non-TCC bladder cancer
•3.Trial entry recurrence identified within 11.5 months of the date of the original diagnosis
•4.Any prior treatment of the trial entry recurrence (including biopsy)
•5.Previous MMC chemotherapy other than a single instillation at diagnostic surgery
•6.Known allergy to MMC
•7.Carcinoma involving the prostatic urethra or upper urinary tract (participants should have had imaging of the upper urinary tract within 2 years prior to randomisation)
•8.Known or suspected reduced bladder capacity (<100ml)
•9.Significant bleeding disorder
•10.Female patients who are breast-feeding or are of childbearing potential and unwilling or unable to use adequate non-hormonal contraception. Male patients should also use contraception if sexually active.
•11.Active or intractable urinary tract infection
•12.Urethral stricture or anything impeding the insertion of a catheter
•13.Large narrow neck diverticula
•14.Significant urinary incontinence
•15.Any other conditions that in the Principal Investigator’s opinion would contraindicate protocol treatment
•16.Unable or unwilling to comply with study procedures or follow up schedule

发起方