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NCT07772206
Single Fraction and Multifraction Arc-Based Radiotherapy for Painful Bone Metastases
Conditions: Bone Metastases of a Malignant Tumor, Cancer Pain
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 70
Sponsor: Oman Ministry of Health
Location: Royal Hospital Muscat Muḩāfaz̧at Masqaţ
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.
Eligibility Criteria
Inclusion Criteria:
* Age ≥18 years
* Histologically proven malignancy
* Radiological evidence of bone or spine metastases
* Pain score ≥4 on Numeric Rating Scale (NRS-11)
* ECOG Performance Status 0-3
* Life expectancy ≥3 months.
* Ability to provide written informed consent
Exclusion Criteria:
* Spinal cord compression requiring emergency therapy
* Previous radiotherapy to same site
* Unstable pathological fracture requiring surgery
* Pregnancy
* Inability to provide consent
* Oligometastatic bone metastases requiring Stereotactic Body Radiotherapy (SBRT)
Source: ClinicalTrials.gov (NCT07772206). StuddyBuddy aggregates publicly available trial information.