About this trial
This prospective randomised pilot feasibility study will compare single-fraction radiotherapy (8 Gy × 1) with multifraction radiotherapy (20 Gy in 5 fractions) for the palliation of painful bone metastases. The study will evaluate pain response at 4 weeks following radiotherapy, together with feasibility, treatment compliance, toxicity, pain flare, retreatment, patient convenience and resource utilisation. The study will generate preliminary data to inform the design of a future definitive randomised trial.
Eligibility criteria
Qualifiers
Age ≥18 years
Histologically proven malignancy
Radiological evidence of bone or spine metastases
Pain score ≥4 on Numeric Rating Scale (NRS-11)
Disqualifiers
Spinal cord compression requiring emergency therapy
Previous radiotherapy to same site
Unstable pathological fracture requiring surgery
Pregnancy
Trial design
Treatments tested in this trial
- Single-Fraction Radiotherapy (8Gy x 1#)
- Multifraction Radiotherapy (20 Gy in 5 #)
Treatment groups
Sponsors and collaborators
Oman Ministry of Health
Lead sponsor
Royal Hospital, Oman
Collaborator