Targeted therapy with or without nephrectomy in metastatic renal cell carcinoma

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 270

Inclusion Criteria

•Age > 18 and < 75 years
•Written informed consent
•ECOG Performance Status 0-1
•Favorable or intermediate MSKCC or Heng risk score
•Biopsy (primary tumour or metastases) confirming the diagnosis of predominantly clear cell RCC
•Resectable asymptomatic in situ primary (asymptomatic primary is defined as the absence of symptoms which can be exclusively assigned to the primary tumor such as flank pain and/or gross hematuria necessitating blood transfusion.)
•Tumour suitable to nephrectomy in the opinion of the urologist. Patients with Inferior vena cava thrombosis can be included
•Documented metastatic disease (CT scan or MRI)
•Life expectancy > or = 24 weeks
•Up to three different metastatic sites
• = 3 metastatic lesions
•Platelets = 100,000/ml
•Haemoglobin = 9.0 g/dl
•neutrophils >1,500/mm3
•Bilirubin < or = 2 mg/dl, except for patients affected by Gilbert’s syndrome
•AST and ALT < or = 2.5 times the UNL
•Serum albumin = the LNL
•Patients of childbearing age should use contraceptive methods during the study

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 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180

Exclusion Criteria

•Prior surgery or systemic treatment for mRCC
•Bilateral RCC
•Brain and liver metastases
•Non-clear-cell histology
•Poor prognosis as defined by MSKCC or Heng criteria
•Documented widespread disease (> or =4 metastatic organ sites)
•Oligometastatic disease suitable of metastasectomy (<3 lesions confined at one organ site)
•Symptomatic primary tumour at presentation
•High surgical risk in the opinion of the urologist
•Patients with > 3 of the following surgical risk factors are not eligible:
-Serum albumin CTCAE v 4.0 grade 2 or worse
-Serum LDH > 1.5 times upper limit of normal
-Symptoms at presentation due to metastases
-Clinical stage T4 disease

- History of malabsorption syndrome
•Pregnant or breastfeeding women
•Concomitant cardiac disorders: cardiac failure NYHA> 2; Acute coronary syndrome or myocardial infarction or severe or unstable angina within the last 6 months as well as uncontrolled hypertension (sistolic>160, diastolic>90), arrhytmia requiring treatment (except for beta blockers or digossin)
•Uncontrolled diabetes
•Deep phlebitis not treated with LMWH or arterial thrombosis within the last 6 months
•HIV infection
•Active infections (> Grade 2 NCI-CTC v.3.0)
•Patients with active bleeding or with pathological conditions increasing the risk of bleeding
•Other cancer within the previous 5 years (except for in situ skin carcinoma, superficial bladder Ta, Tis, T1 and carcinoma of the cervix or every cancer with curative treatment within 5 years)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To compare clinical benefit, as measured by OS, provided by CN followed by TKIs vs upfront TKIs in subjects with mRCC;Secondary Objective: -To compare clinical benefit, as measured by PFS and response rate (RR) provided by CN followed by TKIs vs upfront TKIs<br>-Safety<br>;Primary end point(s): Overall Survival (OS);Timepoint(s) of evaluation of this end point: time interval between the randomization and the time of death for any cause

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Progression-free survival; Overall response rate;Timepoint(s) of evaluation of this end point: From randomization to disease progression or death of the subject; From randomization to disease progression or death of the subject

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