Randomized Phase III Trial Evaluating the Importance of Nephrectomy in Patients Presenting With Metastatic Renal Cell Carcinoma Treated With Sunitinib
The 2 previous studies on the impact of nephrectomy (EORTC, SWOG) in metastatic renal cell
carcinoma have justified recommendation to initial nephrectomy for patients presenting with
metastatic renal cell carcinoma. But these studies were performed at the time of
The objective is Evaluation of the importance of nephrectomy in patients with metastatic
renal cell carcinoma treated with sunitinib (AA) Arm A : Nephrectomy followed by Sunitinib
Arm B : Sunitinib alone Sunitinib will be administrated orally daily for 4 weeks followed
by a 2 week rest( schedule 4/2), 6 weeks are considered as a cycle The starting dose will be
50 mg daily with provision for dose reduction based on tolerability Patient will be treated
until disease progression or unacceptable toxicity occurrence or withdraw.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary endpoint is overall survival.
starting at 4 months
Arnaud Mejean, MD PhD
Assistance Publique - Hôpitaux de Paris
France: Ministry of Health