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Single Fraction and Multifraction Arc-Based Radiotherapy for Painful Bone Metastases
Sponsor: Oman Ministry of Health
Summary
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.
Official title: The SMART Trial: A Randomised Feasibility Study Comparing Single Fraction and Multifraction Arc-Based Radiotherapy for Painful Bone Metastases
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
70
Start Date
2026-09-01
Completion Date
2027-12-30
Last Updated
2026-08-19
Healthy Volunteers
No
Interventions
Single-Fraction Radiotherapy (8Gy x 1#)
VMAT-based external beam radiotherapy planned to deliver 8 Gy in a single fraction with CBCT-based image guidance for the palliation of painful bone metastasis
Multifraction Radiotherapy (20 Gy in 5 #)
VMAT-based external beam radiotherapy planned to deliver 20 Gy in Five fractions of 4 Gy each with daily CBCT-based image guidance for the palliation of painful bone metastasis
Locations (1)
Royal Hospital
Muscat, Muḩāfaz̧at Masqaţ, Oman