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NCT05115331 · ClinicalTrials.gov registry record · Phase 3
Palliative UNConventional Hypofractionation Trial for Metastatic Bone Disease
A Phase 3 study of Metastatic Bone Tumor, sponsored by University of Cincinnati.
- Active
- Registry status
- Phase 3
- Development phase
- 168
- Enrollment target
- 1
- Study location
NCT05115331: Active Phase 3 study of Metastatic Bone Tumor, sponsored by University of Cincinnati.
NCT05115331 is a Phase 3 study of Metastatic Bone Tumor that is active but no longer recruiting, run by University of Cincinnati. The registered enrollment target is 168 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05115331, a Phase 3 study of Metastatic Bone Tumor, is active but no longer recruiting, sponsored by University of Cincinnati.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 168 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
A primary objective evaluate the efficacy of the addition of a second 8 Gy fraction administered 1 week following the standard 8 Gy treatment currently utilized for palliation of symptomatic bone metastases in solid cancers, as measured by pain response at 1 month. The primary endpoint for this objective is pain response which will be determined using the Brief Pain Inventory (BPI) at one month.
Conditions Studied
Interventions
- RADIATION Experimental Radiation Dose
- RADIATION Conventional Radiation Dose
Study Locations (1)
Ohio
- University of Cincinnati - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2021-11-24 |
| Est. Completion | 2025-11-24 |
| Phase | Phase 3 |
What the registry record for NCT05115331 still lists
NCT05115331 is an interventional study that assigns participants to a tested intervention. The registered 168 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (78% lower).
The record links to 1 condition, with Metastatic Bone Tumor appearing as the primary indexed condition, and to 2 interventions - of which Experimental Radiation Dose is the first listed.
NCT05115331 reports a single indexed study location in Ohio.
Frequently Asked Questions
What is clinical trial NCT05115331 about?
NCT05115331 is a clinical study titled "Palliative UNConventional Hypofractionation Trial for Metastatic Bone Disease". 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 basel...
What is the current status of trial NCT05115331?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 168 participants. The study started on 2021-11-24. Estimated completion is 2025-11-24.
What conditions does trial NCT05115331 study?
This clinical trial studies the following conditions: Metastatic Bone Tumor.
What interventions are being tested in trial NCT05115331?
The interventions under investigation include: Experimental Radiation Dose (RADIATION), Conventional Radiation Dose (RADIATION).
Who is sponsoring clinical trial NCT05115331?
This trial is sponsored by University of Cincinnati, which has 245 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05115331 being conducted?
This trial has 1 study location across Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05115331's enrollment target sits among peer trials
168 1460th of 2000 higher than 538 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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