cT2a N0NxM0 Renal Tumor Clinical Trial
Official title:
An Open-label, Non-randomized, Multicenter, Two Stage Designed Phase II Study of Axitinib for Downstaging Large Renal Tumors Not Primarily Suitable for Partial Nephrectomy (AXIPAN)
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.
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