Clinical Trial to Assess the Importance of Nephrectomy

Recruitment & Eligibility

Inclusion Criteria

age ≥ 18 years
ECOG Performance Status 0 - 1
Biopsy (primary tumour or metastases) confirming the diagnosis of clear cell carcinoma
Documented metastatic disease
Absence of prior systemic treatment for kidney cancer including AA
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.
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.
Platelets > or = 100 x 109/L, haemoglobin >or = 9 g/dl, neutrophils >or = 1.5 x 109/L;
Bilirubin < or = 2 mg/dL, aspartate transaminase (ASAT) and alanine transaminase (ALAT)< or = 2.5 times the upper normal limit (UNL) or < or = 5 times UNL for patients with liver metastases
Patients of child bearing age should use contraceptive methods
Patient able to follow the procedures outlined in the protocol as far as the planning of visits and examinations are concerned.
Life expectancy ≥ 3 months
Written informed consent
Patient without brain metastases or with radiotherapy or surgery treated brain metastases without progression into 6 weeks and non treated by corticoid
Patient non treated by anticoagulants excepted HBPM

Exclusion Criteria

Prior systemic treatment for kidney cancer (including Anti Angiogenic)
Bilateral kidney cancer
Pregnant or breast feeding women
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 not treated with low molecular weight heparin or arterial thrombosis within the last 3 months
Patients being treated with antivitamin K with curative intent (please note that patients being treated with low molecular weight heparin can be included)
Medical, general or psychiatric difficulties which, in the opinion of the Investigator, would make it inappropriate for trial entry
Symptomatic or untreated brain metastases (patients with brain metastases that have been treated by radiotherapy or surgery and have stable disease within 6 weeks, and are not requiring treatment with corticosteroids can be included)
Previous history of gastric disease or malabsorption, syndrome compromising the absorption of Sunitinib
Experimental treatment within the 28 days preceding inclusion
Other cancer within the previous 5 years (except for insitu skin carcinoma and treated localised prostate cancer with undetectable PSA)
Patient has received treatment with IV biphosphonate

Study & Design

Arm && Interventions

Group	Intervention	Description
A	Nephrectomy	Nephrectomy + sunitinib
B	Sunitinib alone	Sunitinib alone

Primary Outcome Measures

Name	Time	Method
The primary endpoint is overall survival.	starting at 4 months

Secondary Outcome Measures

Name	Time	Method
Progression-Free Survival	Starting at 4 months
Objective Response (complete or partial) is evaluated according to RECIST 1.1 criteria	Starting at 4 months
Clinical benefit (complete response, partial or stable for at least 12 weeks).	Starting at 4 months
Non-compliance to Sunitinib treatment is evaluated in arm A (nephrectomy + sunitinib) as the percentage of patients not starting sunitinib treatment within 6 weeks after nephrectomy	Starting at 4 months
Non-compliance to sunitinib treatment is evaluated in arm B (sunitinib alone) as the percentage of patients needing nephrectomy	Starting at 4 months
Post operative morbidity is evaluated as the percentage of deaths within 30 days following nephrectomy	Starting at 4 months

Recruitment & Eligibility