SUNITINIB TREATMENT OF RENAL ADJUVANT CANCER (S-TRAC): A RANDOMIZED DOUBLE-BLIND PHASE 3 STUDY OF ADJUVANT SUNITINIB VS. PLACEBO IN SUBJECTS WITH HIGH RISK RCC

Update Il y a 4 ans
Reference: EUCTR2006-004024-37

Woman and Man

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Extract

To demonstrate an improvement in disease-free survival (DFS) in high risk (per modified UISS criteria) subjects with RCC randomly assigned to adjuvant sunitinib 50 mg schedule 4/2: 4 weeks on, 2 weeks off for 1 year (Arm A), vs. Placebo (Arm B) after nephrectomy.


Inclusion criteria

  • Adjuvant treatment of subjects with “high risk” Renal Cell Carcinoma (RCC) following nephrectomy