Clinical Trial

Palliative UNConventional Hypofractionation Trial for Metastatic Bone Disease

Study acronym: 1-2 PUNCH
Active, Not Recruiting Phase 3
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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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2021-10-29; most recent amendment 2025-05-27.
Status change: Recruiting → Active, Not Recruiting 2025-05-27
Status change: Not Yet Recruiting → Recruiting 2021-11-24
Trial Details
NCT Number NCT05115331
Lead Sponsor University of Cincinnati
Conditions Metastatic Bone Tumor
Enrollment 168 participants
Start Date 2021-11-24
Primary Completion 2023-07-13 (estimated)
Study Completion 2025-11-24 (estimated)
Updated on ClinicalTrials.gov 2025-05-31