Randomized phase III trial evaluating the importance of nephrectomy in patients presenting with metastatic renal cell carcinoma treated with sunitinib

HS Greater Glagsow and Clyde (UK)0 个研究点目标入组 450 人开始时间: 2011年11月3日最近更新: 2022年11月7日

适应症

试验速览

2018 Results article in https://www.ncbi.nlm.nih.gov/pubmed/29860937 results (added 10/04/2019)

•1. Age = 18 years
•2. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 1
•3. Biopsy (primary tumour or metastases) confirming the diagnosis of clear cell carcinoma alone or preponderant
•4. Documented metastatic disease
•5. Absence of prior systemic treatment for kidney cancer including anti angiogenic (AA)
•6. Tumour amenable to nephrectomy (partial or total) in the opinion of the patient?s urologist. Patients presenting with an inferior vena cava thrombosis can be included.
•7. Patients for which the indication of Sunitinib is considered according to the recommendations rules given by national health authorities of participating countries. The prescription of Sunitinib in the circumstances of the study is considered as a standard treatment
•8. Platelets 100 x 109/L, haemoglobin > 9 g/dl, neutrophils >1.5 x 109/L
•9. Bilirubin < 2 mg/dL, aspartate transaminase (ASAT) and alanine transaminase (ALAT), 2.5 times the upper normal limit (UNL) or 5 times UNL for patients with liver metastases
•10. Patients of child bearing age should use contraceptive methods
•11. Patient able to follow the procedures outlined in the protocol as far as the planning of visits and examinations are concerned
•12. Life expectancy = 3 months
•13. Written informed consent

•1. Prior systemic treatment for kidney cancer (including anti angiogenic)
•2. Bilateral kidney cancer
•3. Pregnant or breast feeding women
•4. Acute coronary syndrome or episode of myocardial infarction or severe or unstable angina within the last 6 months as well as severe diabetes with severe peripheral arteriopathy or deep phlebitis or arterial thrombosis within the last 3 months
•5. Anticoagulant therapy in treatment dose
•6. Medical, general or psychiatric difficulties which, in the opinion of the Investigator, would make it inappropriate for trial entry
•7. Brain metastases
•8. Previous history of gastric disease or of malabsorption compromising the absorption of Sunitinib
•9. Experimental treatment within the 28 days preceding inclusion
•10. Other cancer within the previous 5 years [except for insitu skin carcinoma and treated localised prostate cancer with undetectable Prostate-specific antigen (PSA)]

发起方

HS Greater Glagsow and Clyde (UK)