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.
Comparing Radiation Therapy to Usual Care for Patients With High-Risk Bone Asymptomatic Metastases
Radiation Therapy for High-Risk Asymptomatic Bone Metastases: A Pragmatic Multicenter Randomized Phase 3 Clinical Trial (PREEMPT)
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Overview
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Study details
- Patients with polymetastatic cancer defined as more than 5 sites of radiographically-evident systemic metastatic disease (excluding intracranial disease).
- 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.
- Previous radiotherapy to the intended enrolled sites of disease
- Epidural spinal cord compression (ESCC) ≥ grade 1c (defined as deformation of the thecal sac with spinal cord abutment) at the enrolled bone metastasis(es)
- Prior fracture at the enrolled bone metastasis(es)
1) Active Comparator: Arm I (standard of care) Patients continue to receive SOC systemic anti-cancer therapy or observation and bone modifying agents as determined by the treating physician. Additionally, patients optional blood sample collection on study. Interventions: Other: Best Practice Other: Patient Observation Other: Bone Metastases Treatment Procedure: Biospecimen Collection Other: Questionnaire Administration 2) Experimental: Arm II (RT, SOC) Patients continue SOC as in Arm I. Patients also undergo conventional RT or SBRT QD for up to 5 days (5 fractions) in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo CT or MRI and optional blood sample collection on study. Interventions: Other: Best Practice Other: Patient Observation Other: Bone Metastases Treatment Procedure: Biospecimen Collection Other: Questionnaire Administration