Non-clear Cell Renal Cell Cancer Clinical Trial
Official title:
Prospective Randomized Phase-II Trial With Temsirolimus Versus Sunitinib in Previously Untreated Patients With Advanced or Metastatic Non-Clear Cell Renal Carcinoma
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment