1. Accelerated Middle Half Body Radiotherapy in Bone Metastases from Prostate Cancer: A Phase I Study (SHARON Project)
- Author
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Alessandra Arcelli, Alice Zamagni, Francesco Cellini, Francesco Deodato, Gabriella Macchia, Savino Cilla, Alessio G. Morganti, E. Farina, Giambattista Siepe, Milly Buwenge, Silvia Cammelli, Zamagni A., Buwenge M., Macchia G., Siepe G., Cilla S., Cellini F., Arcelli A., Farina E., Deodato F., Cammelli S., and Morganti A.G.
- Subjects
Male ,Cancer Research ,Maximum Tolerated Dose ,medicine.medical_treatment ,Prostate neoplasm ,Bone Neoplasms ,Bone Neoplasm ,Follow-Up Studie ,Prostate cancer ,Phase I ,medicine ,Clinical endpoint ,Humans ,Palliative therapy ,Settore MED/36 - DIAGNOSTICA PER IMMAGINI E RADIOTERAPIA ,Aged ,Radiotherapy ,business.industry ,Bone metastases ,Prostatic Neoplasms ,Radiotherapy Dosage ,General Medicine ,Middle Aged ,medicine.disease ,Combined Modality Therapy ,Phase i study ,Radiation therapy ,Bone metastase ,Treatment Outcome ,Oncology ,Maximum tolerated dose ,Cohort ,Toxicity ,Prostatic Neoplasm ,Quality of Life ,Nuclear medicine ,business ,Human ,Follow-Up Studies - Abstract
Background/aim The primary endpoint of this phase I study was the maximum tolerated dose (MTD) of middle half body (MHB) accelerated radiotherapy (RT) in multiple bone metastatic (BM) prostate cancer (PCa) patients. Patients and methods Three step dose escalation [13 Gy (3.25 Gy/fraction), 14 Gy (3.5 Gy/fraction), and 15 Gy (3.75 Gy/fraction)] in three consecutive patient cohorts were planned. RT was delivered in two consecutive days and two daily fractions. Six patients were enrolled in the first two cohorts and 12 in the third cohort. Grade ≥3 toxicity was considered as a dose-limiting toxicity (DLT). Results Twenty-five patients (median age=71 years, median follow-up=7.4 months) were enrolled. Defined MTD dose was 15 Gy. Overall pain response rate was 76%: 9 patients (36%) showed complete and 10 patients (40%) reported partial response of pain. Conclusion MHB accelerated RT (total dose: 15 Gy) delivered in two consecutive days and two daily fractions is well tolerated.
- Published
- 2019