Bone metastases Cancer
Conditions
Interventions
Intervention: No immediate post-operative radiotherapy (within 10 weeks of surgery): Routine clinical monitoring will be undertaken and if patients develop progressive local symptoms radiotherapy may
Sponsors
Royal Orthopaedic Hospital NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Main PORTRAIT trial: 1. The patient is over 18 years old. 2. The patient has had surgery for a pathological fracture or impending fracture due to metastatic bone disease in the long bones of the arms and legs (metastatic carcinoma or myeloma). 3. The patient is able to provide informed consent to take part in the study. Incentive SWAT 1. Any participant who is due to be sent their four month follow up questionnaire, will be eligible for the incentive SWAT.
Exclusion criteria
Exclusion criteria: Main PORTRAIT trial: 1. Index surgical procedure is undertaken for spinal metastases. 2. Index surgical procedure is a revision of failed previous surgery for metastatic bone disease. 3. Index surgical procedure is for a bone sarcoma or associated metastases. 4. Index surgical procedure is for a known or suspected lymphoma. 5. Patient is undergoing non-surgical management of an impending or pathological fracture (e.g. sling, plaster of Paris). 6. Patient has a life expectancy estimated to be less than 4 months. 7. Patient has had previous radiotherapy targeting the surgically treated bone. 8. Patient is participating in another study evaluating the effectiveness of radiotherapy for treatment of bone metastases. 9. Patient previously participated in the PORTRAIT study. 10. Patient is currently pregnant. Incentive SWAT: 1. Any participant who has withdrawn from the main PORTRAIT trial will be excluded from the recognition SWAT.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain interference measured using the Brief Pain Inventory (BPI) at 4 months post-randomisation | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain severity is measured using the Brief Pain Inventory (BPI) mean severity score at 4, 8, 12, and approximately 18 months post-randomisation 2. Pain response is measured using the International Consensus Pain Response Endpoints (ICPRE) at 4, 8, 12, and approximately 18 months post-randomisation 3. Quality-adjusted life years are measured using the EQ-5D-5L at 4, 8, 12, and approximately 18 months post-randomisation 4. Patient-reported functional status is measured using the Toronto Extremity Salvage Score (TESS) at 4, 8, 12, and approximately 18 months post-randomisation 5. Overall survival is measured using clinical follow-up data at 4, 8, 12, and approximately 18 months post-randomisation 6. Revision surgical rates are measured using clinical records at 4, 8, 12, and approximately 18 months post-randomisation 7. Time to re-operation is measured using clinical records at 4, 8, 12, and approximately 18 months post-randomisation 8. Re-irradiation for pain is measured using clinical records at 4, 8, 12, and approximately 18 months post-randomisation 9. Time to re-irradiation is measured using clinical records at 4, 8, 12, and approximately 18 months post-randomisation 10. Resource use is measured using health economic data collection tools at 4, 8, 12, and approximately 18 months post-randomisation 11. Cost-effectiveness is measured using health economic modelling based on EQ-5D-5L and resource use data at 4, 8, 12, and approximately 18 months post-randomisation 12. Adverse events are measured using clinical records and patient reports at 4, 8, 12, and approximately 18 months post-randomisation | — |
Countries
England, Northern Ireland, Scotland, United Kingdom
Outcome results
None listed