Single Fraction and Multifraction Arc-Based Radiotherapy for Painful Bone Metastases

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorOman Ministry of Health

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

70 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Oman Ministry of Health

Lead sponsor

Royal Hospital, Oman

Collaborator