This will be a prospective, open-label, randomized multicenter phase-II study to evaluate progression free survival (PFS) in patients with locally advanced or metastatic non-clear cell renal cell cancer (ncc-RCC) receiving Temsirolimus in comparison to Sunitinib. In most clinical trials in renal cell carcinoma (RCC), clear cell RCC have been included exclusively. There are only some limited data on the efficacy of Temsirolimus or Sunitinib in ncc-RCC showing interesting response rates for both agents. However, randomized clinical trials in this specific patient population have not yet been performed. In the proposed study a comparison Temsirolimus and Sunitinib is scheduled in first line therapy of ncc-RCC.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
22
25 mg intravenously, once weekly infusion
50 mg oral once daily for 4 weeks, followed by 2 weeks rest.
Charité - Campus Virchow Klinikum
Berlin, Germany
Charité - Mitte
Berlin, Germany
Vivantes Klinikum am Urban
Berlin, Germany
Evangelische Kliniken Bonn gGmbH - Johanniter-Krankenhaus
Bonn, Germany
Universitätsklinikum Düsseldorf
Düsseldorf, Germany
Universitätsklinikum Essen
Essen, Germany
Klinikum der J.W. Goethe Universität
Frankfurt, Germany
Martin-Luther-Universität Halle-Wittenberg
Halle, Germany
Universitätskrankenhaus Jena
Jena, Germany
UK-SH Campus Lübeck
Lübeck, Germany
...and 4 more locations
Time to progression
Time frame: 7-11 months expected
Objective response
Time frame: 7-11 months expected
safety assessed using CTCAE v3.0 and safety assessed according to reported SAEs
Time frame: 8-12 months (treatment duration + 1 months)
one year progression free survival rate (1YPFSR)
Time frame: 1 year
overall survival (OS)
Time frame: will be evaluated in 2013
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