StudyFinder
Comparing Radiation Therapy to Usual Care for Patients With High-Risk Bone Asymptomatic Metastases, PREEMPT Trial
RECRUITING
18 years and over
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)
* No prior fracture at the enrolled bone metastasis(es)OTHER: Best Practice, PROCEDURE: Biospecimen Collection, OTHER: Bone Metastases Treatment, PROCEDURE: Computed Tomography, PROCEDURE: Conventional Radiotherapy, PROCEDURE: Magnetic Resonance Imaging, OTHER: Patient Observation, OTHER: Questionnaire Administration, RADIATION: Stereotactic Body Radiation Therapy
Metastatic Malignant Neoplasm in the Bone, Metastatic Malignant Solid Neoplasm
ctrrecruit@vcu.edu
NCT06745024