Sorafenib in Elderly Patients With Metastatic Renal Cell Carcinoma
Status:
Terminated
Trial end date:
2015-09-01
Target enrollment:
Participant gender:
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