Cabozantinib in the Elderly With Metastatic Renal Cell Carcinoma

Active, not recruiting

Brief Summary: The purpose of this study is to evaluate the safety and efficacy of Cabozantinib in the treatment of patients with renal cell carcinoma.

Recruitment & Eligibility

Inclusion Criteria

Age 70 years
Histological diagnosis of Renal Cell Carcinoma (any histology, with the exclusion of urothelial carcinomas)
Locally advanced disease or metastatic disease (any site, measurable or non- measurable lesions), progressing after at least one line of VEGFR-targeted therapy (as per official registration of the drug at AIFA, in case of extension to first-line treatment, TKI-naïve patients will also be eligible), with or without previous exposure to check-point inhibitors.
Life expectancy of at least 3 months
Adequate hepatic, renal and bone marrow function as judged by the treating oncologist.
Written informed consent

Exclusion Criteria

Inability to swallow cabozantinib tablets
Serious comorbidities or cognitive impairment, which may interfere with cabozantinib administration and/or patient's follow up, as judged by the treating physician
Absence of a reliable caregiver, as judged by the treating physician

Primary Outcome Measures

Name	Time	Method
Clinical tolerability of Cabozantinib	Average of 1 year	the main purpose is to register the Incidence of Treatment-Emergent Adverse Events \[Safety and Tolerability\]

Secondary Outcome Measures

Name	Time	Method
Description of response rate of patients treated with Cabozantinib.	From date of randomization until the date of last documented, assessed up to 18 months"	according to RECIST criteria, only patients with measurable disease will be evaluated for response

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