1. Palliative short-course radiotherapy in advanced pelvic cancer: A phase II study (SHARON project)
- Author
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E. Farina, Alice Zamagni, Flora Anna Mauro, Savino Cilla, Francesco Cellini, M.A. Sumon, Luciana Caravatta, Kamal A.F.M. Uddin, Erica Scirocco, Domenico Genovesi, Giambattista Siepe, Biniyam Tefera Deressa, Silvia Cammelli, Milly Buwenge, Francesco Deodato, Wondemagegnehu Tigeneh, Gabriella Macchia, Alessio G. Morganti, Farina E., Macchia G., Siepe G., Zamagni A., Buwenge M., Scirocco E., Cellini F., Deressa B.T., Tigeneh W., Uddin K.A.F.M., Sumon M.A., Caravatta L., Genovesi D., Mauro F.A., Cammelli S., Cilla S., Morganti A.G., and Deodato F.
- Subjects
Quality of life ,Adult ,Male ,Cancer Research ,medicine.medical_specialty ,Pelvic Neoplasm ,Palliative care ,Maximum Tolerated Dose ,Pelvi ,medicine.medical_treatment ,Phases of clinical research ,Pain ,Pelvis ,03 medical and health sciences ,0302 clinical medicine ,80 and over ,medicine ,Humans ,Pelvic Neoplasms ,Radiation Injuries ,Radiation Injurie ,Dose Fractionation ,Pelvic cancer ,Settore MED/36 - DIAGNOSTICA PER IMMAGINI E RADIOTERAPIA ,Aged ,Neoplasm Staging ,Aged, 80 and over ,Radiation ,Radiotherapy ,business.industry ,Palliative Care ,Cancer ,Radiotherapy Dosage ,General Medicine ,Middle Aged ,medicine.disease ,Phase II ,Surgery ,Radiation therapy ,Regimen ,Oncology ,030220 oncology & carcinogenesis ,Female ,Dose Fractionation, Radiation ,Accelerated Radiation Therapy ,business ,Human - Abstract
Aim To define safety and efficacy of a palliative, short-course accelerated radiation therapy for symptomatic locally advanced primary pelvic cancer. Materials and methods A phase II trial was planned based on the minimax Simon's two-stage design. A total of 18 Gy in 4.5 Gy/fraction administered twice a day was delivered (SHARON). Pain and quality of life were recorded according to the Visual Analogue self-assessment and the cancer linear analog scales (CLAS), respectively. Results Twenty-five patients were enrolled in the study. The most frequent baseline symptoms were pain (48%), bleeding (40%), bleeding/pain (8%), and intestinal sub-occlusion (4%). The overall palliative response rate was 96.0%, with a median palliative duration of 6 months. An improvement of quality-of-life indices (well-being, fatigue, and ability to perform daily activities) was noted in 64.0%, 36.0%, and 48.0% of patients, respectively. Conclusion The SHARON regimen was well tolerated and effective in the palliative treatment of patients with locally advanced pelvic cancer. Based on these results, a multicentric prospective phase III trial is ongoing to compare this regimen with traditional 2-week radiotherapy treatment.
- Published
- 2019