Radiation Therapy for High-Risk Asymptomatic Bone Metastases: A Pragmatic Multicenter Randomized Phase 3 Clinical Trial (PREEMPT)

Cancer Categories

Sarcoma

Karmanos Trial ID

NRG-CC014

NCT ID

NCT06745024

Age Group

Adult

Scope

National

Phase

Phase III

Principal Investigator

Brian
Yeh, M.D., Ph.D.
Oncology - Radiation View Profile

Objective:

Primary Objective

To determine whether prophylactic radiation therapy (RT) to high-risk asymptomatic bone metastases decreases the occurrence of skeletal-related events (SREs), including pathologic fracture, spinal cord compression, and surgery to bone (not including palliative radiation for pain only), compared to standard of care (SOC).

Secondary Objectives

To compare overall survival (OS) between study arms.
To compare occurrence of any SREs (including RT for palliation of pain) among enrolled bone metastasis(es) between study arms.
To compare occurrence of hospitalizations related to any SREs in enrolled bone metastasis(es) between study arms.
To compare pain-related quality of life (QOL) between study arms.
To characterize adverse events of RT and compare to SOC.

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Eligibility

Inclusion Criteria:

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) (Brief Pain Inventory [BPI] score of < 5 on the "maximum" pain item) 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

Patients with any solid tumor type (excluding multiple myeloma)
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)

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Applicable Disease Site

Therapies, Drugs, Devices