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

NCT07772206 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2026-08-19

No results posted yet for this study

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.

Conditions

  • Bone Metastases of a Malignant Tumor
  • Cancer Pain

Interventions

RADIATION

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

RADIATION

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

Sponsors & Collaborators

  • Royal Hospital, Oman

    collaborator OTHER_GOV

  • Oman Ministry of Health

    lead OTHER_GOV

Principal Investigators

  • Balaji Subramanian Sitaraman, MBBS, DNB · Royal Hospital, Ministry of Health, Oman

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2027-12-01
Completion
2027-12-30

Countries

  • Oman

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07772206 on ClinicalTrials.gov