Comparing Radiation Therapy to Usual Care for Patients With High-Risk Bone Asymptomatic Metastases

Launched by NRG ONCOLOGY · Dec 17, 2024

Keywords

ClinConnect Summary

This clinical trial is studying whether adding radiation therapy to the usual care can help prevent problems related to high-risk bone metastases in cancer patients who do not have symptoms. High-risk bone metastases are cancer spreads in the bones that are larger than 2 centimeters or located in critical areas like the hips or spine. The trial aims to find out if using radiation therapy, which uses high-energy x-rays to target cancer cells, can reduce complications like fractures or severe pain compared to standard treatments, which might involve monitoring or medications to strengthen bones.

To be eligible for this trial, participants must be adults aged 18 or older with a specific type of cancer that has spread to more than five areas of the body, excluding the brain. They should have asymptomatic bone metastases that meet certain criteria, such as size or location. Participants will be treated with radiation either in one session or over several days, alongside their regular cancer care. This trial is not yet recruiting participants, but it hopes to help determine the best way to manage and prevent complications from high-risk bone metastases in cancer patients.

Gender

ALL

Eligibility criteria

• 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 (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
• • NOTE: 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)
• Exclusion Criteria:
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