Status:
RECRUITING
Biology-Guided Radiation Therapy for the Treatment of Patients With Bone Metastases
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Metastatic Malignant Neoplasm in the Bone
Metastatic Malignant Solid Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This clinical trial tests the safety and effectiveness of a single-dose treatment of biology-guided radiation therapy (BgRT) in treating patients with painful cancer that has spread from where it firs...
Detailed Description
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 rela...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
July 26 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 26 2027
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06549478
Start Date
July 26 2024
End Date
January 26 2027
Last Update
September 17 2025
Active Locations (1)
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1
City of Hope Medical Center
Duarte, California, United States, 91010