Conditions: Kidney Neoplasms
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 674
Healthy volunteers: no

Brief summary:
To compare the disease free survival time and safety of sunitinib with placebo in adjuvant treatment patients at high risk of recurrent kidney cancer after surgery.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Sunitinib malate intervention 2: Placebo
Intervention descriptions: intervention 1: sunitinib malate 50 mg PO on schedule 4/2: 4 weeks on, 2 weeks off for 1 year or until disease recurrence or occurrence of a secondary malignancy, significant toxicity, or withdrawal of consent. intervention 2: Placebo PO for 1 year on schedule 4/2: 4 weeks on, 2 weeks off or until disease recurrence or occurrence of a secondary malignancy, significant toxicity, or withdrawal of consent

Protocol document: