Study of whether radiotherapy after surgery to treat a weakened or broken bone caused by cancer helps to reduce pain and improve quality of life
| ISRCTN | ISRCTN76027709 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76027709 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Not applicable |
| Integrated Research Application System (IRAS) | 333375 |
| Protocol serial number | CPMS 58239, NIHR159676 |
| Sponsor | Royal Orthopaedic Hospital NHS Foundation Trust |
| Funder | National Institute for Health and Care Research |
- Submission date
- 16/10/2025
- Registration date
- 30/10/2025
- Last edited
- 30/10/2025
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
People with advanced cancers, like breast or prostate cancer, often develop bone problems that can lead to painful fractures. These are called pathological fractures and usually need surgery to fix or replace the damaged bone. After surgery, many patients are given radiotherapy to help with pain and healing. However, there’s no strong evidence that this treatment actually helps. Radiotherapy can also cause side effects, delay other treatments, and take up NHS resources. This study aims to find out whether giving radiotherapy after surgery really improves pain and quality of life, or if it’s just adding extra burden without enough benefit.
Who can participate?
Adults who are having surgery to treat bone fractures caused by cancer (not including spine surgery) may be able to take part. The study is looking to include 350 people from across the UK.
What does the study involve?
Participants will be randomly placed into one of two groups. One group will receive radiotherapy within 10 weeks after surgery. The other group will not receive radiotherapy during that time but will be monitored closely. If symptoms get worse, radiotherapy may be offered later. Everyone in the study will be followed up for up to 18 months to see how they’re doing in terms of pain, quality of life, and other health outcomes.
What are the possible benefits and risks of participating?
Taking part could help researchers understand whether radiotherapy after surgery is truly helpful. This could improve care for future patients. Risks may include side effects from radiotherapy (for those who receive it), and the time and effort involved in attending follow-up appointments and completing questionnaires. Participants may also be offered different types of incentives to help encourage them to stay in the study.
Where is the study run from?
Royal Orthopaedic Hospital (UK)
When is the study starting and how long is it expected to run for?
September 2024 to May 2029
Who is funding the study?
National Institute for Health and Care Research (NIHR) (UK)
Who is the main contact?
Ms Lydia Flett, ytu-portrait@york.ac.uk
Plain English summary under review with external organisation
Contact information
Scientific
York Trials Unit
Department of Health Sciences
Faculty of Sciences
ARRC Building
University of York
Heslington
York
YO10 5DD
United Kingdom
 ORCID ID |
0000-0002-8280-826X |
|---|---|
| Phone | +44 (0)800 915 4992 |
| ytu-portrait@york.ac.uk |
Scientific, Principal investigator
Royal Orthopaedic Hospital
Bristol Road South
Northfield
Birmingham
B31 2AP
United Kingdom
| ORCID ID |
0000-0002-2869-6455 |
|---|---|
| jonathan.stevenson@nhs.net |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Interventional randomized controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Post-Operative RadioTheRApy In surgically Treated bone metastases (PORTRAIT): a multi-centre, randomised controlled trial |
| Study acronym | PORTRAIT |
| Study objectives | Primary objective: To undertake a multi-centre, two-arm, parallel group, RCT to determine whether no immediate radiotherapy (within the first 10 weeks after surgery) is non-inferior to immediate radiotherapy (within the first 10 weeks) following surgery for bone metastases in terms of pain interference measured by the Brief Pain Inventory (BPI) at four months post-randomisation. Secondary objectives: 1. To undertake a 12-month internal pilot to determine the feasibility of the study, in particular recruitment rate and completeness of follow-up 2. To undertake an analysis of secondary outcomes to assess the impact of radiotherapy on pain interference and severity, quality of life, functional status, survival and rate of re-operation at 4-, 8-, 12-, and up to 18-months post randomisation. 3. To determine the cost-effectiveness of the two treatment options from the NHS perspective to inform the most efficient provision of future NHS care. 4. To undertake a Study within a Trial (SWAT) to evaluate the effectiveness of different types of incentives (cash vs voucher) on participant retention at the primary end point. |
| Ethics approval(s) | Approved 18/07/2025, North East – Tyne & Wear South Research Ethics Committee (Address: Not available; +44 (0)2071048120, +44 (0)207 104 8286; tyneandwearsouth.rec@hra.nhs.uk), ref: 25/NE/0124 |
| Health condition(s) or problem(s) studied | Bone metastases |
| Intervention | 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 be offered after this period. Comparator: Immediate post-operative radiotherapy (within 10 weeks of surgery): Delivered using the preferred regimen of the treating Clinical Oncologist 4-10 weeks following surgery. |
| Intervention type | Other |
| Primary outcome measure(s) |
Pain interference measured using the Brief Pain Inventory (BPI) at 4 months post-randomisation |
| Key secondary outcome measure(s) |
1. Pain severity is measured using the Brief Pain Inventory (BPI) mean severity score at 4, 8, 12, and approximately 18 months post-randomisation |
| Completion date | 31/05/2029 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 350 |
| Key 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. |
| Key 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. |
| Date of first enrolment | 01/09/2025 |
| Date of final enrolment | 30/11/2027 |
Locations
Countries of recruitment
- United Kingdom
- England
- Northern Ireland
- Scotland
Study participating centres
Bristol Road South
Northfield
Birmingham
B31 2AP
United Kingdom
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom
Leicester
LE1 5WW
United Kingdom
Edgbaston
Birmingham
B15 2GW
United Kingdom
Taunton
TA1 5DA
United Kingdom
Liverpool Road
Chester
CH2 1UL
United Kingdom
Glasgow
G4 0SF
United Kingdom
Glasgow
G51 4TF
United Kingdom
Belfast
BT9 7AB
United Kingdom
Derby Road
Nottingham
NG7 2UH
United Kingdom
Old Dalkeith Road
Edinburgh
Lothian
EH16 4SA
United Kingdom
Walsall
WS2 9PS
United Kingdom
Aberdeen
AB25 2ZN
United Kingdom
Bristol
BS2 8HW
United Kingdom
Sutton-in-ashfield
NG17 4JL
United Kingdom
Exeter
EX2 5DW
United Kingdom
Leeds
LS7 4SA
United Kingdom
Cobalt Business Park
Newcastle upon Tyne
NE27 0QJ
United Kingdom
Herries Road
Sheffield
S5 7AU
United Kingdom
Dalmellington Road
Ayr
KA6 6AB
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study (fully anonymised) will be available upon request after the publication of the study. Requests for access to data will be reviewed by the Chief Investigator, York Trials Unit (YTU), and the study Sponsor. Requests should be sent to the relevant contacts listed within this study record. Participants will be informed that information collected about them may be shared anonymously with other researchers and will be asked to consent to this. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
16/10/2025: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).
