Comparing Radiation Therapy to Usual Treatment for Patients With High-Risk Bone Metastases That Are Not Causing Pain, PREEMPT Trial

Running, not enrolling · Phase 3

Conditions studied: Metastatic Malignant Neoplasm in the Bone, Metastatic Malignant Solid Neoplasm

In brief

This phase III trial compares the effect of adding radiation therapy to usual treatment on the occurrence of bone-related complications in cancer patients with high-risk bone metastases that are not causing symptoms, such as pain (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 treatment 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 treatment may be more effective in preventing bone-related complications than usual care alone in cancer patients with asymptomatic high-risk bone metastases.

Key facts

Study ID

NCT06745024

Run by

NRG Oncology

People needed

280

Starts

2025-05-07

Expected to finish

2029-02-01

Last updated by the study team

2026-06-25

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with polymetastatic cancer defined as more than 5 sites of radiographically-evident systemic metastatic disease (excluding intracranial disease)
• "High-risk" asymptomatic bone metastasis(es) (defined as pain score of < 5 on a 0-10 scale using question #3 from the Brief Pain Inventory [BPI]) defined as fulfilling at least one of the following four high-risk criteria:
• Bulky site of disease in bone (>= 2 cm);
• Disease involving the hip (acetabulum, femoral head, femoral neck), shoulder (acromion, glenoid, humeral head), or sacroiliac joints;
• Disease in long bones occupying up to 2/3 of the cortical thickness (humerus, radius, ulna, clavicle, femur, tibia, fibula, metacarpals, phalanges); and/or
• Disease in junctional spine (C7-T1, T12-L1, L5-S1) and/or disease with posterolateral element (pedicles and/or facet joints) involvement.
• NOTES:
• Patients may have up to 3 individual high-risk bone metastases enrolled in the study. Sternum, rib, and scapula are defined as flat bones so lesions in these locations would only be included if bulky (per high-risk criteria #1)
• Question #3 from the Brief Pain Inventory (BPI): "On a scale of 0-10, 0 being no or least amount of pain, and 10 being the worst pain imaginable, what score would you rate your worst pain in the last 24 hours."
• The pain score can be lesion-specific and does not need to refer to overall pain.
• The remaining questions on the BPI are not required to confirm eligibility
• Patients with any solid tumor type (excluding multiple myeloma and lymphoma)
• Patients must have systemic disease evaluation through standard of care diagnostic imaging, including either CT chest/abdomen/pelvis or body positron emission tomography (PET)/CT, with radiology report available
• Patients with treated brain metastases and no known leptomeningeal disease are eligible if these lesions have been treated prior to enrollment
• Age ≥ 18
• Performance status: Eastern Cooperative Oncology Group (ECOG) 0-2 or Karnofsky performance status (KPS) ≥ 60
• No previous radiotherapy to the intended enrolled sites of disease
• No epidural spinal cord compression (ESCC) ≥ grade 1c (defined as deformation of the thecal sac with spinal cord abutment) at the enrolled bone metastasis(es)
• No prior fracture at the enrolled bone metastasis(es)

Where it is running

• Banner MD Anderson Cancer Center — Gilbert, Arizona, United States
• Cancer Center at Saint Joseph's — Phoenix, Arizona, United States
• Banner-University Medical Center Phoenix — Phoenix, Arizona, United States
• Banner University Medical Center - Tucson — Tucson, Arizona, United States
• University of Arizona Cancer Center-North Campus — Tucson, Arizona, United States
• Kaiser Permanente-Anaheim — Anaheim, California, United States
• Kaiser Permanente-Deer Valley Medical Center — Antioch, California, United States
• Mission Hope Medical Oncology - Arroyo Grande — Arroyo Grande, California, United States
• Sutter Auburn Faith Hospital — Auburn, California, United States
• Sutter Cancer Centers Radiation Oncology Services-Auburn — Auburn, California, United States
• AIS Cancer Center at San Joaquin Community Hospital — Bakersfield, California, United States
• Kaiser Permanente-Bellflower — Bellflower, California, United States
• Alta Bates Summit Medical Center-Herrick Campus — Berkeley, California, United States
• Mills-Peninsula Medical Center — Burlingame, California, United States
• Sutter Cancer Centers Radiation Oncology Services-Cameron Park — Cameron Park, California, United States
• Mercy Cancer Center - Carmichael — Carmichael, California, United States
• Mercy San Juan Medical Center — Carmichael, California, United States
• Eden Hospital Medical Center — Castro Valley, California, United States
• City of Hope Corona — Corona, California, United States
• City of Hope Comprehensive Cancer Center — Duarte, California, United States
• Kaiser Permanente Dublin — Dublin, California, United States
• Mercy Cancer Center - Elk Grove — Elk Grove, California, United States
• UC San Diego Health System - Encinitas — Encinitas, California, United States
• Kaiser Permanente-Fremont — Fremont, California, United States
• Fairbanks Memorial Hospital — Fairbanks, Alaska, United States

Full record on ClinicalTrials.gov

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