Pain REduction with bone metastases STereotactic radiotherapy (PREST): A phase III randomized multicentric trial
| Autor: | Maria Antonietta Gambacorta, Vincenzo Valentini, Francesco Cellini, Alessio G. Morganti, Giambattista Siepe, C.M. Donati, Antonia Salatino, Vincenzo Fusco, V. Borzillo, Anna Santacaterina, Rossella Di Franco, Matteo Muto, Antonino D'Agostino, Francesco Pastore, Paolo Muto, Salvatore Parisi, Savino Cilla, Stefano Pergolizzi, Renzo Corvò, Stefania Manfrida, Giampaolo Montesi, Fabio Arcidiacono, Valeria Masiello, Francesco Deodato, Ernesto Maranzano, Mario Santarelli |
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| Přispěvatelé: | Cellini F., Manfrida S., Deodato F., Cilla S., Maranzano E., Pergolizzi S., Arcidiacono F., Di Franco R., Pastore F., Muto M., Borzillo V., Donati C.M., Siepe G., Parisi S., Salatino A., D'Agostino A., Montesi G., Santacaterina A., Fusco V., Santarelli M., Gambacorta M.A., Corvo R., Morganti A.G., Masiello V., Muto P., Valentini V. |
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
medicine.medical_specialty
medicine.medical_treatment Analgesic Medicine (miscellaneous) Radiosurgery 030218 nuclear medicine & medical imaging law.invention Lesion 03 medical and health sciences Study Protocol 0302 clinical medicine Quality of life Randomized controlled trial law Outcome Assessment Health Care medicine Clinical endpoint Humans Simultaneous integrated boost Pharmacology (medical) Progression-free survival Pain control Settore MED/36 - DIAGNOSTICA PER IMMAGINI E RADIOTERAPIA Randomised controlled trial lcsh:R5-920 Spinal Neoplasms medicine.diagnostic_test business.industry Bone metastases Magnetic resonance imaging Cancer Pain Magnetic Resonance Imaging Radiation therapy Bone metastase 030220 oncology & carcinogenesis Radiology Radiotherapy Intensity-Modulated medicine.symptom lcsh:Medicine (General) business |
| Zdroj: | Trials Trials, Vol 20, Iss 1, Pp 1-7 (2019) |
| Popis: | 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 ( Discussion The primary endpoint is overall pain reduction, defined in terms of variation between baseline and 3-month evaluation; pain will be measured using the NRS. Secondary endpoints include pain control duration; retreatment rates (after a minimum interval of 1 month); local control assessed with RECIST criteria; symptom progression free survival; progression-free survival; overall survival; and quality of life (at 0, 30, and 90 days). Accrual of 330 lesions is planned. The experimental arm is expected to have an improvement in overall pain response rates of 15% with respect to the standard arm (60% according to Chow et al. (Int J Radiat Oncol Biol Phys. 82(5):1730–7, 2012)). Trial registration ClinicalTrials.gov, NCT03597984. Registered on July 2018. |
| Databáze: | OpenAIRE |
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