title: 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.forename: Giuseppe
authors.initials: G
authors.lastname: Procopio
authors.forename: Elena
authors.initials: E
authors.lastname: Verzoni
authors.forename: Pamela
authors.initials: P
authors.lastname: Biondani
authors.forename: Paolo
authors.initials: P
authors.lastname: Grassi
authors.forename: Isabella
authors.initials: I
authors.lastname: Testa
authors.forename: Enrico
authors.initials: E
authors.lastname: Garanzini
authors.forename: Filippo
authors.initials: F
authors.lastname: de Braud
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D002173:Cancer Care Facilities; D002292:Carcinoma, Renal Cell / Q000097:blood / Q000188:drug therapy* / Q000556:secondary / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D002985:Clinical Protocols; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D005346:Fibroblast Growth Factors / Q000097:blood; D006801:Humans; D007558:Italy; D007680:Kidney Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D059146:Metastasectomy; D008875:Middle Aged; D009536:Niacinamide / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018579:Patient Selection; D010671:Phenylurea Compounds / Q000008:administration & dosage / Q000627:therapeutic use*; D047428:Protein Kinase Inhibitors / Q000008:administration & dosage / Q000627:therapeutic use*; D012107:Research Design; D000077157:Sorafenib; D042461:Vascular Endothelial Growth Factor A / Q000097:blood
chemical_list: D000970:Antineoplastic Agents; D010671:Phenylurea Compounds; D047428:Protein Kinase Inhibitors; C467484:VEGFA protein, human; D042461:Vascular Endothelial Growth Factor A; D009536:Niacinamide; D005346:Fibroblast Growth Factors; D000077157:Sorafenib