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

• DOI: 10.1186/s13063-019-3676-x
• Publication Date: 2019-10-28T11:09:06Z
• Authors: Francesco Cellini; Stefania Manfrida; Francesco Deodato; Savino Cilla; Ernesto Maranzano; Stefano Pergolizzi; Fabio Arcidiacono; Rossella Di Franco; Francesco Pastore; Matteo Muto; Valentina Borzillo; Costanza Maria Do...; Giambattista Siepe; Salvatore Parisi; Antonia Salatino; Antonino D’Agostino; Giampaolo Montesi; Anna Santacaterina; Vincenzo Fusco; Mario Santarelli; Maria Antonietta ...; Renzo Corvò; Alessio Giuseppe ...; Valeria Masiello; Paolo Muto; Vincenzo Valentini
• Keywords: Clinical endpoint; Target lesion

Abstract Background Palliative antalgic treatments represent an issue for clinical management and a challenge scientific research. Radiotherapy (RT) plays 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 SBRT is still lacking. Methods/design The PREST trial was designed interventional study without medicinal treatment. It 3, open-label, multicentric randomized 1:1. Inclusion criteria include painful spinal bone metastases presenting pain level > 4 (or 1 if being treated analgesic) on the Numeric Rating Scale (NRS); expected intermediate/high prognosis (greater than 6 months) according to Mizumoto prognostic score; low spine instability neoplastic score (SINS) sores (< 7); magnetic resonance imaging (MRI) assessment bulky lesion. Patients will be assigned either standard conventional involving Gy × 5 fractions (fx) whole involved vertebra or by intensity modulated simultaneous integrated boost (IMRT-SIB) 7 3 fx + 10 macroscopic lesion (gross tumor volume (GTV)). In experimental arm, GTV contoured registration baseline MRI. Discussion primary endpoint overall reduction, defined terms variation between 3-month evaluation; measured using NRS. Secondary endpoints control duration; retreatment rates (after minimum interval month); local assessed RECIST criteria; progression free survival; progression-free quality life (at 0, 30, 90 days). Accrual 330 lesions planned. arm have improvement response 15% respect (60% Chow et al. (Int J Radiat Oncol Biol Phys. 82(5):1730–7, 2012)). Trial ClinicalTrials.gov, NCT03597984 . Registered July 2018.