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Palliative UNConventional Hypofractionation Trial for Metastatic Bone Disease

NCT05115331 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 168

Last updated 2025-05-31

No results posted yet for this study

Summary

This is a randomized Phase III study evaluating the efficacy of hypofractionated and dose-escalated palliative radiation therapy in metastatic bone disease (MBD). Patients will be randomized 1:1 to the conventional (8 Gy in a single fraction) and experimental (16 Gy in 2 fractions) groups with baseline and subsequent assessment of both pain and quality of life metrics.

Conditions

  • Metastatic Bone Tumor

Interventions

RADIATION

Experimental Radiation Dose

16 Gy in 2 fractions

RADIATION

Conventional Radiation Dose

8 Gy in a single fraction

Sponsors & Collaborators

  • University of Cincinnati

    lead OTHER

Principal Investigators

  • Timothy Struve, MD · University of Cincinnati

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-24
Primary Completion
2023-07-13
Completion
2025-11-24

Countries

  • United States

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 NCT05115331 on ClinicalTrials.gov