Pain REduction with bone metastases STereotactic radiotherapy (PREST): A phase III randomized multicentric trial

  • Francesco Cellini (Creator)
  • Stefania Manfrida (Creator)
  • Francesco Deodato (Creator)
  • Savino Cilla (Creator)
  • Ernesto Maranzano (Creator)
  • Stefano Pergolizzi (Creator)
  • Fabio Arcidiacono (Creator)
  • Rossella Di Franco (Contributor)
  • Francesco Pastore (Creator)
  • Matteo Muto (Creator)
  • Valentina Borzillo (Creator)
  • Costanza Maria Donati (Creator)
  • Giambattista Siepe (Creator)
  • Salvatore Parisi (Creator)
  • Antonia Salatino (Creator)
  • Antonino D'Agostino (Contributor)
  • Giampaolo Montesi (Creator)
  • Anna Santacaterina (Creator)
  • Vincenzo Fusco (Creator)
  • Mario Santarelli (Creator)
  • Maria Antonietta Gambacorta (Creator)
  • Renzo Corvo' (Creator)
  • Alessio Giuseppe Morganti (Creator)
  • Valeria Masiello (Creator)
  • Paolo Muto (Creator)
  • Vincenzo Valentini (Catholic University of the Sacred Heart, Fondazione Policlinico Universitario Agostino Gemelli IRCCS) (Creator)

Dataset

Description

Abstract Background Palliative antalgic treatments represent an issue for clinical management and a challenge for scientific research. Radiotherapy (RT) plays a central role. Techniques such as stereotactic body radiotherapy (SBRT) were largely investigated in several phase 2 studies with good symptom response, becoming widely adopted. However, evidence from randomized, direct comparison of RT and SBRT is still lacking. Methods/design The PREST trial was designed as an interventional study without medicinal treatment. It is a phase 3, open-label, multicentric trial randomized 1:1. Inclusion criteria include painful spinal bone metastases presenting with a pain level > 4 (or > 1 if being treated with an analgesic) on the Numeric Rating Scale (NRS); expected intermediate/high prognosis (greater than 6 months) according to the Mizumoto prognostic score; low spine instability neoplastic score (SINS) sores (
Dati resi disponibili2019
Editorefigshare

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