A Phase III randomised trial of PeriOperative chemotherapy versus sUrveillance in upper Tract urothelial cancer

Institute for Cancer Research (UK)0 个研究点目标入组 261 人开始时间: 2012年1月31日最近更新: 2020年4月27日

适应症

试验速览

•1. Written informed consent
•2. >or =18 years of age
•3. Post radical nephro-ureterectomy for upper tract tumour with predominant TCC component - squamoid differentiation or mixed TCC/ small cell carcinoma (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; Target Gender: Male & Female ; Lower Age Limit 18 no age limit or unit specified

•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. Glomerular filtration rate (GFR) <30 ml/minute. Gemcitabine-carboplatin can only be given for patients with suboptimal renal function for cisplatin ie for GFR 30-49ml/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, carcinoma in situ (CIS) of cervix or Lobular carcinoma in situ (LCIS) of breast or localised prostate cancer in patients who have a life expectancy of over 5 years upon trial entry

发起方

Institute for Cancer Research (UK)