Clear Cell Renal Cell Carcinoma Clinical Trial
Official title:
"PADRES" (Prior Axitinib as a Determinant of Outcome of REnal Surgery)
This is a single arm phase II study of axitinib in patients with clear cell renal cell
carcinoma (RCC) with strong indications for partial nephrectomy (PN) for whom PN is not
currently possible due to anatomic considerations and residual renal function concerns.
Evaluation of tumor downsizing will be performed including changes of tumor complexity by
nephrometry score. A total of 50 participants will be enrolled.
It is hypothesized that pretreatment with axitinib will be safe and improve the feasibility
of complex nephron sparing surgery in select patients with localized clear cell RCC and
imperative indications for partial nephrectomy.
The primary objective of the study is to prospectively assess utility of axitinib in
facilitation of partial nephrectomy where partial nephrectomy was not thought to be
safe/possible in the setting of imperative indication for complex renal masses in renal cell
cancer.
Secondary objectives: To determine the safety, tumor diameter (per RECIST v1.1) volume
change, surgical morbidity and renal functional outcomes following neoadjuvant axitinib for
RCC.
Anatomical/morphometric:
1. tumor diameter/volume change,
2. conversion of hilar to non-hilar tumors,
3. reduction in RENAL morphometric score.
Functional Considerations:
1. Requirement of acute dialysis
2. Change in Glomerular Filtration Rate (GFR)
3. Whether or not GFR crosses 30 threshold, or decline by GFR to >50% of baseline.
Safety indices:
1. Incidence of Clavien >3 complications
2. Avoidance of need for multiple blood transfusions
;
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