A Phase III randomised trial of Peri-Operative chemotherapy versus sUrveillance in upper Tract urothelial cancer - POUT

Institute of Cancer Research0 个研究点目标入组 345 人开始时间: 2011年12月9日最近更新: 2012年9月25日

适应症

试验速览

暂无简介。

•1.Written informed consent
•2.=18 years of age
•3.Post radical nephroureterectomy for upper tract tumour with predominant TCC component - squamoid differentiation or mixed TCC/SCC is permitted.
•4.Histologically confirmed TCC staged pT2-pT4 pN0-3 M0 or pTany N1-3 M0 (providing all grossly abnormal nodes are resected). Patients with microscopically positive margins on pathology may be entered (providing all grossly abnormal disease was resected).
•5.Satisfactory haematological profile (ANC> 1.5 x 109/L, platelet count 100 x 10/L ) and liver function tests (bilirubin < 1.5 x ULN, AST and Alkaline phosphatase < 2.5 x ULN), Glomerular filtration rate = 30 mls/min.
•6.Fit and willing to receive adjuvant chemotherapy with first cycle to be commenced within 90 days of radical nephro-ureterectomy if allocated
•7.WHO performance status 0-1.
•8.Available for long-term follow-up
•Are the trial subjects under 18? no
•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 145
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 200

•1.Evidence of distant metastases
•2.Pure adenocarcinoma, squamous cell carcinoma or small cell or other variant histology
•3.Un-resected macroscopic nodal disease
•4.Concurrent muscle invasive bladder cancer (patients with concurrent Non-muscle invasive bladder cancer (NMIBC) will be eligible)
•5.GFR <30 mls/minute. NB Gemcitabine-carboplatin can only be given for patients with suboptimal renal function for cisplatin ie for GFR 30-49mls/min. Patients with poor performance status or co-morbidities that would make them unfit for chemotherapy are ineligible for the trial
•6.Significant co-morbid conditions that would interfere with administration of protocol treatment
•7.Pregnancy; lactating women or women of childbearing potential unwilling or unable to use adequate non-hormonal contraception (male patients should also use contraception if sexually active);
•8.Previous malignancy in the last 5 years except for previous NMIBC, adequately controlled non melanoma skin tumours, CIS of cervix or LCIS of breast or localised prostate cancer in patients who have a life expectancy of over 5 years upon trial entry.

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