Open-label, randomized multicentre phase II study to assess the efficacy and tolerability of sunitinib by dose administration regimen (dose modification or dose interruptions) in patients with advanced or metastatic renal cell carcinoma: study protocol of

Fiche publication


Date publication

avril 2018

Journal

Trials

Auteurs

Membres identifiés du Cancéropôle Est :
Dr THIERY-VUILLEMIN Antoine, Dr MOUILLET Guillaume, Dr VERNEREY Dewi


Tous les auteurs :
Mouillet G, Paillard MJ, Maurina T, Vernerey D, Nguyen Tan Hon T, Almotlak H, Stein U, Calcagno F, Berthod D, Robert E, Meurisse A, Thiery-Vuillemin A

Résumé

Sunitinib is a tyrosine kinase inhibitor approved in the first-line metastatic renal cell carcinoma (MRCC) setting at the dose of 50 mg daily for 4 weeks followed by a pause of 2 weeks. Due to toxicity, this standard schedule (50 mg daily 4/2) can induce up to 50% of sunitinib dose modification (reduction and/or interruption). The current recommendation in such case is to reduce the dose to 37.5 mg per day (standard schedule 4/2). Recent data highlight an alternative schedule: 2 weeks of treatment followed by 1 week of pause (experimental schedule 2/1). The SURF trial is set up to evaluate prospectively experimental schedule 2/1 when toxicity occurs. This article displays the key elements of the study protocol.

Mots clés

Health-related quality of life, Metastatic, Renal cell carcinoma, Safety, Schedule, Sunitinib, Toxicity

Référence

Trials. 2018 Apr 12;19(1):221