eo-adjUvant veRsus AdjuvaNt chemotherapy in Upper Tract Urothelial Carcinoma: A feaSibility phase II randomized clinical trial (URANUS”) - URANUS version NL 2.2 November 21, 2017

European Uro-Oncology Group (EUOG)0 个研究点目标入组 210 人开始时间: 2017年3月31日最近更新: 2019年6月30日

试验速览

暂无简介。

•written informed consent
•Age = 18 years.
•Histological and radiological defined UTUC: Histologically-confirmed diagnosis of predominantly urothelial carcinoma of the upper urinary tract
•Patients with UTUC cT2-pT4 cN0-N1 M0 (TNM classification)
•Women of childbearing potential must have a negative serum pregnancy test within 14 days of first dose of study treatment and agree to use effective contraception during the study and for 14 days following the last dose of study treatment.
•Patients without bladder cancer or with concomitant non muscle invasive bladder cancer
•Adequate organ system function defined by Hematological results: Absolute neutrophil count (ANC) ?1.5 X 109/L; Haemoglobin ?5.6 mmol/L ( =9.02g/dL); Platelets ?100 X 109/L; Prothrombin time (PT) or international normalized ratio (INR)b ?1.2 X ULN; Activated partial thromboplastin time (aPTT)?1.2 X ULN. Hepatic: Total bilirubin?1.5 X ULN; Alanine amino transferase (ALT) and Aspartate aminotransferase (AST) ?2.5 X ULN. Renal: GRF < or ?55 ml/min: Electrolytes: potassium, magnesium and calcium: within normal limits.
•CT scan of the chest, abdomen and pelvis and bone scan without evidence of distant metastasis
•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 100
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 125

•Histology of pure adenocarcinoma, pure squamous cell carcinoma, sarcomatoid or predominant small cell carcinoma.
•History of cardiovascular conditions within the past 6 months.
•Incidentally found asymptomatic pulmonary embolism (PE) or recent deep vein thrombosis (DVT) is not an exclusion criteria but requires anticoagulation treatment.
•Subjects receiving anticoagulant therapy are eligible if their INR is stable and within the recommended range for the desired level of anticoagulation.
•Any major contraindication to a surgical procedure.
•Any serious and/or unstable pre-existing medical, psychiatric, or other condition that could interfere with subject’s safety, provision of informed consent, or compliance to study procedures.
•Active infection contraindicating chemotherapy (under investigator criteria).
•Concomitant diseases that are a formal exclusion to platinum-based chemotherapy (deafness, grade II neuropathy).
•Other active neoplasms. Patients with in situ cervical carcinoma, non-melanoma skin cancer or prostate cancer T1 Gleason <7, PSA <10. Patients with past medical history of cancer can be included if diagnosed at least 5 years ago.
•Concomitant muscle invasive bladder cancer.
•Patients who have been or still are on methotrexate treatment.

发起方

European Uro-Oncology Group (EUOG)