Trial Outcomes

• The primary endpoint of the trial will be pain control 5 weeks after the start of the radiotherapy, as assessed by the Brief Pain Inventory. A clinically significant response will be a decrease of 2 points or more in the ‘worst pain’ component of the Brief Pain Inventory.

• Secondary endpoints will include acute toxicity, quality of life, overall survival and radiological response.

• Exploratory endpoints will include changes in strong opioid dose in addition to predictive and response biomarker studies for radiotherapy.

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