Biology-Guided Radiation Therapy for the Treatment of Patients With Bone Metastases
NCT ID: NCT06549478
Last Updated: 2025-09-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
24 participants
INTERVENTIONAL
2024-07-26
2027-01-26
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Treatment (BgRT)
Patients undergo a single fraction of BgRT on day 0. Patients undergo PET/CT on study and optionally during follow up.
Computed Tomography
Undergo PET/CT
Image Guided Radiation Therapy
Undergo BgRT
Positron Emission Tomography
Undergo PET/CT
Questionnaire Administration
Ancillary studies
Interventions
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Computed Tomography
Undergo PET/CT
Image Guided Radiation Therapy
Undergo BgRT
Positron Emission Tomography
Undergo PET/CT
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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)
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Yi-Jen Chen
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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NCI-2024-06473
Identifier Type: REGISTRY
Identifier Source: secondary_id
23937
Identifier Type: OTHER
Identifier Source: secondary_id
23937
Identifier Type: -
Identifier Source: org_study_id
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