Randomized comparison of Sequential therapies with Sunitinib and Sorafenib in Advanced Renal Cell Carcinoma

Authors
Category Primary study
Registry of TrialsUMIN Clinical Trials Registry
Year 2010
INTERVENTION: sunitinib administration, washout period, sorafenib administration sorafenib administration, washout period, sunitinib administration CONDITION: renal cell cancer PRIMARY OUTCOME: PFS in first‐line treatment, Total progression free survival (PFS) in first‐line and second‐line treatments SECONDARY OUTCOME: PFS in second‐line treatment, Antitumor effect, survival, clinical benefit (CR+PR+NC), and adverse event INCLUSION CRITERIA: 1) Age: 20‐80 years old, both inclusive 2) ECOG performance status of 0, 1, or 2 3) MSKCC risk of favorable or intermediate 4) Histologically confirmed renal cell carcinoma 5) No ischemic heart disease 6) Laboratory findings meet the following criteria: (1) Respiratory function: %VC, 80% and FEV1.0,70% (2) Hematology: white blood cell count4,000/mm3, platelet count100,000/mm3 (3) Clinical chemistry: GOT and GPT within the normal range of each medical institution; total bilirubin <1.5 x ULN (4) Serum creatinin <2.0mg/dl, blood urea nitrogen (BUN) <25mg/dl (5) Echocardiographic estimation of left ventricular ejection fraction is higher than the lower limit of reference range of each medical institution.
Epistemonikos ID: bf05253ccf0ecf098ba98186be4d04f2e780c9d5
First added on: Aug 22, 2024