Short course accelerated radiation therapy in palliative care

Palliative radiotherapy is a key resource for symptoms control and improvement patient's life expectancy in advanced stage of illness. The most common symptoms that afflict this type of patients are pain, bleeding, dysphagia, obstruction, vomiting, nausea. Most of these can benefit from a hypo-fractionated radiation treatment with a good percentage of complete responses, variable depending on the symptom considered, but on average 56-70%. Normally a hypo-fractionated treatment, excluding uncomplicated bone metastases where the single fraction (800 cGy in 1 fraction) is the standard, provides for 30 Gy delivered in 10 fractions (1 fraction / day) or 20 Gy in 5 fractions (1 fraction / day). SHARON Project (Short Course Accelerated Radiation Therapy), based on dose-escalation Phase I-II studies that defined the MDT (maximum tolerated dose), is made up of 7 randomized Phase III trials (1:1 on Simon's design) that aim to compare the effectiveness on the symptom control of a conventional hypo-fractionationated radiotherapy compared with an accelerated hypofractionationated treatment. 4 Specifically, the fractionation we propose provides the delivery of 4.5-5 Gy twice a day at a distance of 6-8 hours for two consecutive days. GTV will be identified by macroscopic lesion (detailed in the single protocol), CTV by GTV + a margin of 2 cm and the PTV from CTV + 1 cm of isotropic margin. There will be described the results of the Sharon-Bone Phase I-II trial, Sharon Head and Neck Phase I-II trial and Sharone Elderly (pooled analysis phase I-II trials) and the seven randomized Phase III trials for all the described body regions (Abdomen RT 15-01, Brain RT 15-02, Thorax RT 15-03, Pelvis RT 15-04, H&N RT 15-05, Bone RT 15-06, Esophagus RT 15-07)