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Post-operative radiotherapy in surgically treated bone metastases (PORTRAIT Trial): a multi-centre, two-arm, parallel-group Randomised Controlled Trial

Background

Bone metastases occur when a cancer that started elsewhere in the body spreads to the bones. Approximately 70% of people with advanced breast and prostate cancer develop bone metastases. They often cause pain and, when the metastasis damages the bone, they can lead to a fracture. When this happens surgery can be carried out to strengthen or replace the affected bone. Following surgery, patients are usually referred for radiotherapy. Radiotherapy aims to reduce pain and lower the chances that further surgery will be needed in future. However, despite its widespread use, there is no high-quality evidence showing it helps to improve pain and quality of life or reduces the need for further surgery. Radiotherapy has side-effects, requires additional hospital visits and scan appointments, and can delay patients getting more effective treatments. This can cause patients distress and anxiety. It is therefore essential to understand if this treatment provides benefits for patients to justify the additional harms and cost.

Aims and objectives

To undertake a multi-centre, two-arm, parallel group randomised controlled trial to determine whether no external beam radiotherapy, following surgical stabilisation of impending or completed pathological fracture due to bone metastasis in adults is noninferior to radiotherapy for pain, function, and quality of life following surgery. The primary outcome is pain interference at four months post-randomisation - measured using the Brief Pain Inventory (BPI).  Secondary outcomes include: resource use and cost-effectiveness; quality of life (EQ5D-5L); pain severity measured using the BPI; pain response as defined using the International Consensus on Palliative Radiotherapy Endpoints (ICPRE); patient reported functional status using the Toronto extremity salvage score (TESS); revision of surgical rates and time to re-operation; overall survival; and subsequent delivery of radiotherapy to operated site for pain and time to (re)-irradiation. 

Methods: 

A multi-centre, two arm, parallel group, non-inferiority RCT, with an internal pilot trial and embedded economic evaluation.

• Target Population: Patients aged 18 years and over who have had surgery for a pathological fracture or impending fracture due to metastatic bone disease in the long bones of the arms and legs.
• Control: Post-operative radiotherapy, delivered within standard care pathways 4-10 weeks post-operatively.
• Intervention:  No radiotherapy but the participant will be clinically monitored.  If participants develop progressive local symptoms radiotherapy may be offered at this point.  
• Sample size: 350 participants will be randomised 1:1
• Estimated Recruitment Period: 30 months (target date for first enrolment June 2025. 
• Duration per Participant: Up to 18 months. 
• Study status: The study is currently in set up.  We are due to start recruitment in June 2025.  

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