Two randomized trials in the cytokine era showed that cytoreductive nephrectomy (CN) had a role in metastatic renal cell carcinoma (mRCC), increasing life expectancy. The survival benefit of tyrosine kinase inhibitors (TKIs), including first-line sunitinib and pazopanib, in mRCC has been demonstrated, but the majority of patients enrolled in the pivotal phase III studies had undergone nephrectomy. Therefore it is unknown if similar survival benefit with targeted agents could be achieved without CN. We hypothesize that in these patients CN could increase overall survival (OS) in comparison to targeted therapy without CN. We also will investigate mechanisms of primary and secondary resistance to TKIs in patients with mRCC and identify prognostic or predictive biomarkers.
This is a randomized, open-label, controlled, multicenter phase 3 study comparing sunitinib or pazopanib vs CN followed by sunitinib or pazopanib as first-line therapy for patients with mRCC who have not received surgery and prior systemic treatment for metastatic disease. We will identify 270 patients eligible for randomization. The planned treatment duration per patient will be until progressive disease is observed. Secondary endpoints are the evaluation of progression-free survival (PFS) and response rate and the assessment of the safety profile. Exploratory objectives include the evaluation of circulating tumor cells and circulating tumor DNA and correlation with response/resistance to treatment.
The study is enrolling patients.
The use of CN in addition to targeted therapy in patients with renal cell carcinoma with synchronous metastases could lead to a significant improvement in OS and PFS.
Post author correction
Article Type: CLINICAL TRIAL PROTOCOL
AuthorsElena Verzoni, Raffaele Ratta, Paolo Grassi, Roberto Salvioni, Silvia Stagni, Rosanna Montone, Giovanni Fucà, Vera Cappelletti, Carolina Reduzzi, Ugo De Giorgi, Giuseppe Procopio
- • Accepted on 23/09/2017
- • Available online on 29/11/2017
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- Verzoni, Elena [PubMed] [Google Scholar] 1, * Corresponding Author (firstname.lastname@example.org)
- Ratta, Raffaele [PubMed] [Google Scholar] 1
- Grassi, Paolo [PubMed] [Google Scholar] 1
- Salvioni, Roberto [PubMed] [Google Scholar] 2
- Stagni, Silvia [PubMed] [Google Scholar] 2
- Montone, Rosanna [PubMed] [Google Scholar] 3
- Fucà, Giovanni [PubMed] [Google Scholar] 1
- Cappelletti, Vera [PubMed] [Google Scholar] 4
- Reduzzi, Carolina [PubMed] [Google Scholar] 4
- De Giorgi, Ugo [PubMed] [Google Scholar] 5
- Procopio, Giuseppe [PubMed] [Google Scholar] 1
Department of Medical Oncology, Fondazione IRCCS Istituto Nazionale Tumori, Milan - Italy
Department of Urology, Fondazione IRCCS Istituto Nazionale Tumori, Milan - Italy
Clinical Trial Center, Fondazione IRCCS Istituto Nazionale Tumori, Milan - Italy
Biomarker Unit, Department of Experimental Oncology and Molecular Medicine, Fondazione IRCCS Istituto Nazionale Tumori, Milan - Italy
Department of Medical Oncology, Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (IRST) IRCCS, Meldola (Forlì-Cesena) - Italy