Biology-Guided Radiation Therapy for the Treatment of Patients With Bone Metastases

PRIMARY OBJECTIVE:

I. To evaluate pain response by 14 gray (Gy) single fraction (SF)-BgRT for patients with painful bone metastases.

SECONDARY OBJECTIVE:

I. To evaluate patient-reported health related quality of life (QOL), clinician-rated toxicity per Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0, radiographic evidence of disease progression at treated sites, and rate of re-irradiation.

OUTLINE:

Patients undergo a single fraction of BgRT on day 0. Patients undergo positron emission tomography (PET)/computed tomography (CT) on study and optionally during follow up.

After completion of study treatment, patients are followed up at 2 weeks, 3 months and then every 3 months for up to 1 year.

Inclusion criteria

• Documented informed consent of the participant and/or legally authorized representative

• Assent, when appropriate, will be obtained per institutional guidelines
• Age: ≥ 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• Pathologic diagnosis of cancer
• Painful bone metastases from any solid cancers (i.e., a score of at least 2 on a 0-10 scale, 0 representing no pain and 10 representing maximum pain)
• Concurrent treatment of up to 3 radiation fields is allowed
• Standardized uptake value maximum (SUVmax) of the target bone lesions on diagnostic PET > 6
• Size of the target bone lesion 1.5-5 cm
• Pre-screening assessment confirms that the intervention can be administered without exceeding dose constraint guidelines
• Patients with brain metastases can be included but brain metastases must be treated prior to enrollment and follow up magnetic resonance imaging (MRI) 3 months after treatment shows stable findings
• Life expectancy ≥ 6 months in the opinion of the treating investigators
• Off systemic therapy for at least one week prior and one week after study intervention
• Patients able to complete pain assessment and quality of life surveys who do not have cognitive impairment

Exclusion criteria

• Patients with prior radiation therapy to the treatment sites
• Untreated spinal cord compression
• Pathologic fracture at the evaluated site
• Serious medical comorbidities precluding radiotherapy
• Unable to undergo a PET/CT scan
• Pregnant and/or breastfeeding women are excluded from this study as these agents may have the potential for teratogenic or abortifacient effects
• Judgement by the investigator that the patient is unsuitable to participate in the study and the patient is unlikely to comply with study procedures, restrictions, and requirements
• Prospective participants who, in the opinion of the investigator, may not be able to comply with all study procedures (including compliance issues related to feasibility/logistics, patients who exhibit cognitive impairments/ who are unable to complete study materials: assessments/questionnaires)