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

Giuseppe Procopio, Elena Verzoni, Pamela Biondani, Paolo Grassi, Isabella Testa, Enrico Garanzini, Filippo De Braud

Research output: Contribution to journalArticlepeer-review

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.

Original languageEnglish
JournalTumori
Volume100
Issue number1
Publication statusPublished - 2014

Keywords

  • Antiangiogenic therapy
  • Metastasectomy
  • Renal cell carcinoma
  • Sorafenib

ASJC Scopus subject areas

  • Cancer Research
  • Oncology

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