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

Launched by CITY OF HOPE MEDICAL CENTER · Aug 7, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment called biology-guided radiation therapy (BgRT) for patients who have painful cancer that has spread to their bones. The goal is to see if this innovative approach can provide effective pain relief while being safe for patients. BgRT uses advanced imaging technology to precisely target the areas of pain, allowing for a single dose of radiation instead of multiple treatments, which can be more convenient for patients.

To be eligible for this trial, participants need to be at least 18 years old and have a diagnosis of cancer with painful bone metastases, meaning the cancer has moved to the bones and is causing significant pain. They should also be able to complete pain assessments and quality of life surveys. Participants can expect to receive BgRT treatment, and their pain and quality of life will be monitored throughout the study. This trial is currently recruiting, and it’s important for potential participants to discuss their individual circumstances with their healthcare provider to see if they qualify.

Gender

ALL

Eligibility criteria

• 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)