Axitinib (AXITINIB) is an oral, potent, and selective inhibitor of vascular endothelial growth factor receptors 1, 2, and 3 which has achieved objective response rate of 44.2% in phase II study in cytokine-refractory metastatic renal-cell cancer patients. Pre-surgical treatment with Axitinib could allow a substantial proportion of patients with large organ confined tumors to benefit from NSS. The Objective is to determine the efficacy of Axitinib administered prior to surgery in patients with large organ confined tumors not primarily suitable for NSS (cT2aNoNxM0) for shifting from a radical nephrectomy indication to a nephron sparing procedure.
Radical nephrectomy (RN) is the current standard of care for large organ confined renal tumors. Experience and surgical technical improvements have allowed the feasibility of Nephron Sparing Surgery (NSS) in tumors larger than 4 cm and up to 7cm. Very limited data exist regarding the feasibility and safety of NSS in tumors larger than 7cm. It has been demonstrated that NSS compared to RN offers similar oncological outcome while better preserving renal function and thus improving overall survival. The purpose of this study is to test the possibility of offering patients with large organ confined renal tumors, candidates for radical nephrectomy according to current guidelines the benefit of partial nephrectomy thanks to axitinib neo-adjuvant treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
21
Axitinib is an oral, potent, and selective inhibitor of vascular endothelial growth factor (VEGF) receptors 1, 2, 3 It will be supplied as 1 mg and 5 mg film coated tablets for oral administration in light protecting bottles of 60 tablets.
Bicêtre Hospital
Le Kremlin-Bicêtre, France
The number of patients actually experiencing a partial nephrectomy for a tumor ≤ 7cm
Time frame: At 6 months after beginning of the treatment
Response rate according to RECIST criteria
Time frame: At 30 months after beginning of the treatment
Number of participants with treatment-related serious adverse events and their grades according to CTCAE V4.0.
Time frame: At 30 months after beginning of the treatment
Renal function assessed by serum creatinin
Time frame: At baseline and at 30 months after beginning of the treatment
Renal function assessed by calculated glomerular filtration rate (GFR) according to MDRD formula
Time frame: At baseline and at 30 months after beginning of the treatment
Renal function assessed by renal scintigraphy
Time frame: At baseline and at 30 months after beginning of the treatment
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