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NCT06745024 · ClinicalTrials.gov registry record · Phase 3
Comparing Radiation Therapy to Usual Care for Patients With High-Risk Bone Asymptomatic Metastases, PREEMPT Trial
A Phase 3 study of Metastatic Malignant Solid Neoplasm and Metastatic Malignant Neoplasm in the Bone, sponsored by NRG Oncology.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 280
- Enrollment target
- 20
- Study locations
NCT06745024: Recruiting Phase 3 study of Metastatic Malignant Solid Neoplasm and Metastatic Malignant Neoplasm in the Bone, sponsored by NRG Oncology.
NCT06745024 is a Phase 3 study of Metastatic Malignant Solid Neoplasm and Metastatic Malignant Neoplasm in the Bone that is actively recruiting participants, run by NRG Oncology. The registered enrollment target is 280 participants, above the 203-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (38% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06745024, a Phase 3 study of Metastatic Malignant Solid Neoplasm and Metastatic Malignant Neoplasm in the Bone, is actively recruiting participants, sponsored by NRG Oncology.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 280 participants
- Enrollment target
- 20
- Study locations
Study Summary
This phase III trial compares the effect of adding radiation therapy to usual care on the occurrence of bone-related complications in cancer patients with high-risk bone metastases that are not causing symptoms (asymptomatic). High-risk bone metastases are defined by their location (including hip, shoulder, long bones, and certain levels of the spine), or size (2 cm or larger). These bone metastases appear to be at higher risk of complications such as fracture, spinal cord compression, and/or pain warranting surgery or radiation treatment. Radiation therapy uses high energy x-rays to kill cancer cells and shrink tumors. The total dose of radiation can be delivered in a single day or divided in smaller doses for up to 5 days of total treatment. Usual care for asymptomatic bone metastases may include drugs that prevent bone loss, in addition to the treatment for the primary cancer or observation (which means no treatment until symptoms appear). Evidence has shown that preventative radiation therapy may be effective in lowering the number of bone metastases-related complications, however, it is not known if this approach is superior to usual care. Adding radiation therapy to usual care may be more effective in preventing bone-related complications than usual care alone in cancer patients with asymptomatic high-risk bone metastases.
Primary Outcome
Gray's test will be used to test for statistically significant difference in the distribution of SRE failure times (Gray 1988), accounting for death as a competing risk. The cause specific Cox proportional hazards model will be used to evaluate the treatment effect and stratification variables (Cox 1972). The analysis will be conducted on an intent-to-treat basis using all randomized patients. Analyses of treatment effect will be performed using the Cox proportional hazard model with the stratif
Conditions Studied
Interventions
- PROCEDURE Biospecimen Collection
- PROCEDURE Computed Tomography
- OTHER Best Practice
- OTHER Bone Metastases Treatment
- PROCEDURE Conventional Radiotherapy
Study Locations (20)
California
- Kaiser Permanente-Deer Valley Medical Center - Antioch
- Mission Hope Medical Oncology - Arroyo Grande - Arroyo Grande
- Sutter Auburn Faith Hospital - Auburn
- Sutter Cancer Centers Radiation Oncology Services-Auburn - Auburn
- AIS Cancer Center at San Joaquin Community Hospital - Bakersfield
- Alta Bates Summit Medical Center-Herrick Campus - Berkeley
- Mills-Peninsula Medical Center - Burlingame
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park - Cameron Park
- Mercy Cancer Center - Carmichael - Carmichael
- Mercy San Juan Medical Center - Carmichael
- Eden Hospital Medical Center - Castro Valley
- Kaiser Permanente Dublin - Dublin
- Mercy Cancer Center - Elk Grove - Elk Grove
- UC San Diego Health System - Encinitas - Encinitas
Arizona
- Banner MD Anderson Cancer Center - Gilbert
- Cancer Center at Saint Joseph's - Phoenix
- Banner-University Medical Center Phoenix - Phoenix
- Banner University Medical Center - Tucson - Tucson
- University of Arizona Cancer Center-North Campus - Tucson
Alaska
- Fairbanks Memorial Hospital - Fairbanks
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 280 participants |
| Start Date | 2025-04-14 |
| Est. Completion | 2029-02-01 |
| Phase | Phase 3 |
What NCT06745024 shows while recruiting
NCT06745024 is an interventional study that assigns participants to a tested intervention. The registered 280 participants enrollment target is mid-sized for trials with a published cap, above the 203-participant average among 92 other Metastatic Malignant Solid Neoplasm trials with a reported enrollment target (38% higher).
The record links to 2 conditions, with Metastatic Malignant Solid Neoplasm appearing as the primary indexed condition, and to 5 interventions - of which Biospecimen Collection is the first listed.
NCT06745024 names 20 study sites across 3 states, led by California, Arizona, Alaska.
Frequently Asked Questions
What is clinical trial NCT06745024 about?
NCT06745024 is a clinical study titled "Comparing Radiation Therapy to Usual Care for Patients With High-Risk Bone Asymptomatic Metastases, PREEMPT Trial". This phase III trial compares the effect of adding radiation therapy to usual care on the occurrence of bone-related complications in cancer patients with high-risk bone metastases that are not causing symptoms (asymptomatic). High-risk bone metastases are defined by their location (including hip, s...
What is the current status of trial NCT06745024?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 280 participants. The study started on 2025-04-14. Estimated completion is 2029-02-01.
What conditions does trial NCT06745024 study?
This clinical trial studies the following conditions: Metastatic Malignant Solid Neoplasm, Metastatic Malignant Neoplasm in the Bone.
What interventions are being tested in trial NCT06745024?
The interventions under investigation include: Biospecimen Collection (PROCEDURE), Computed Tomography (PROCEDURE), Best Practice (OTHER), Bone Metastases Treatment (OTHER), Conventional Radiotherapy (PROCEDURE).
Who is sponsoring clinical trial NCT06745024?
This trial is sponsored by NRG Oncology, which has 64 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06745024 being conducted?
This trial has 20 study locations across Alaska, Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06745024's enrollment target sits among peer trials
280 9th of 92 higher than 84 of 92 other Metastatic Malignant Solid Neoplasm trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Metastatic Malignant Solid Neoplasm 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.
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