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Palliative UNConventional Hypofractionation Trial for Metastatic Bone Disease

Study acronym: 1-2 PUNCH
StatusActive, Not Recruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Recruiting to Active, Not Recruiting Primary completion date changed from estimate of Nov 24, 2024 to Jul 13, 2023 · Site details revisedv4 Show 2 more changesShow less
    • Primary completion date changed from estimate of Nov 24, 2024 to Jul 13, 2023
    • Site details revised
  2. Re-verified, no change to tracked fieldsv3
  3. Trial status: Not Yet Recruiting to Recruiting Primary completion date: Nov 15, 2024 to Nov 24, 2024 · Completion date: Nov 15, 2025 to Nov 24, 2025 · Start date changed from estimate of Nov 15, 2021 to Nov 24, 2021 · 1 morev2 Show 4 more changesShow less
    • Primary completion date: Nov 15, 2024 to Nov 24, 2024
    • Completion date: Nov 15, 2025 to Nov 24, 2025
    • Start date changed from estimate of Nov 15, 2021 to Nov 24, 2021
    • Site details revised
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05115331
Lead Sponsor University of Cincinnati
Conditions Metastatic Bone Tumor
Enrollment 168 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov