Rationale and protocol of RESORT, a randomized, open-label, multicenter phase II study to evaluate the efficacy of sorafenib in patients with advanced renal cell carcinoma after radical resection of the metastases.

Abstract	The introduction of targeted agents did not totally resolve the approach to the treatment of metastatic renal cell carcinoma (mRCC) because complete response is rarely achieved. Recent findings seem to indicate that metastasectomy may improve survival. The RESORT study was designed to evaluate the additional clinical benefit of metastasectomy followed by sorafenib in a population of mRCC patients. With the aim of evaluating time to recurrence, 132 patients with mRCC who underwent radical resection of metastases at the time of recurrence after nephrectomy will be randomized to receive either sorafenib or best supportive care. Targeted treatment will be administered for up to 52 weeks or discontinued in the case of disease recurrence or unacceptable toxicity. Patients will be followed for a period of 36 months.
Authors	Giuseppe Procopio, Elena Verzoni, Pamela Biondani, Paolo Grassi, Isabella Testa, Enrico Garanzini, Filippo de Braud
Journal	Tumori (Tumori) 2014 Jan-Feb Vol. 100 Issue 1 Pg. e28-30 ISSN: 2038-2529 [Electronic] United States
PMID	24675507 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
Chemical References	Antineoplastic Agents Phenylurea Compounds Protein Kinase Inhibitors VEGFA protein, human Vascular Endothelial Growth Factor A Niacinamide Fibroblast Growth Factors Sorafenib
Topics	Adult Aged Antineoplastic Agents (administration & dosage, therapeutic use) Cancer Care Facilities Carcinoma, Renal Cell (blood, drug therapy, secondary, surgery) Chemotherapy, Adjuvant Clinical Protocols Disease-Free Survival Drug Administration Schedule Female Fibroblast Growth Factors (blood) Humans Italy Kidney Neoplasms (blood, drug therapy, pathology) Male Metastasectomy Middle Aged Niacinamide (administration & dosage, analogs & derivatives, therapeutic use) Patient Selection Phenylurea Compounds (administration & dosage, therapeutic use) Protein Kinase Inhibitors (administration & dosage, therapeutic use) Research Design Sorafenib Vascular Endothelial Growth Factor A (blood)

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