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Not Yet Recruiting 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)

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07772206). StuddyBuddy aggregates publicly available trial information.