Sunitinib Either Before or After Cytoreductive Nephrectomy in Patients With Metastatic Renal Cell Carcinoma
- To compare the activity of sunitinib malate when administered before vs after
cytoreductive nephrectomy, in terms of response rate, in patients with metastatic renal
- To compare the safety of these regimens in these patients.
- To compare the time to progression in patients treated with these regimens.
- To compare the duration of response in patients treated with these regimens.
- To compare the overall survival of patients treated with these regimens.
OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients undergo cytoreductive nephrectomy. Patients then receive adjuvant
therapy comprising oral sunitinib malate once daily for 4 weeks. Treatment repeats
every 6 weeks for up to 1 year in the absence of disease progression or unacceptable
toxicity. Some patients may continue treatment beyond 1 year at the discretion of the
- Arm II: Patients receive neoadjuvant therapy comprising oral sunitinib malate once
daily for 4 weeks. Treatment repeats every 6 weeks for 2 courses. After completion of
neoadjuvant therapy, patients undergo cytoreductive nephrectomy followed by adjuvant
sunitinib malate as in arm I.
After completion of study therapy, patients are followed every 2 months for up to 1 year.
Allocation: Randomized, Primary Purpose: Treatment
Overall objective tumor response rate (complete response, partial response, stable disease, and progressive disease) as assessed by RECIST criteria
Marco Venturini, MD
Ospedale Sacro Cuore