Sorafenib in Elderly Patients With Metastatic Renal Cell Carcinoma

Summary

Study Design This is a multicenter, open label, first line phase II study in elderly (≥ 65 years old) metastatic Renal Cell Carcinoma (mRCC) patients not suitable for any other currently approved treatment (bevacizumab+INF, cytokines or sunitinib) except for sorafenib. Each patient treated with sorafenib enrolled in the study will be trained to observe the management tool for skin care. A study period of 3 years was estimated as follows: an enrollment period of 24 months and a further follow-up period of 12 months. Objectives of the trial Primary objective The primary aim of this trial is the evaluation of the efficacy of a patient education program in the reduction of Hand-Foot Skin Reaction (HFSR). Secondary Objectives TO assess: * The frequency of dose discontinuation, interruption and reduction * The incidence of any grade diarrhoea, and other adverse events * The overall Response Rate according to the RECIST criteria. * Progression free survival (PFR) in study population and comparison of PFS between age sub groups in the current study population

Timeline

Start

2010-10

Primary completion

2014-09

Completion

2015-09

Outcome

Outcome not reported

Stopped (Enrollment): “low enrollment rate”

Drugs

Indications