Biology-Guided Radiation Therapy for the Treatment of Patients With Bone Metastases
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Computed Tomography, Image Guided Radiation Therapy, Positron Emission Tomography, Questionnaire Administration.
- Who it may be relevant to
- Registry conditions: Metastatic Malignant Neoplasm in the Bone, Metastatic Malignant Solid Neoplasm. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Pilot Study of BgRT for Bone Metastases
Overview
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 first started (primary site) to the bone (bone metastases). Bone metastases can result in significant pain and reduction in quality of life. Single fraction radiation therapy (SFRT) can produce equivalent pain relief compared to multi-fraction radiation therapy, but SFRT treatments generally lead to higher rates of retreatment. BgRT is a new and innovative form of radiation delivery that uses a signal generated by positron emission tomography to guide external beam radiation therapy. It is a technology breakthrough that uses live, continuously updated data throughout the entire treatment session to determine exactly where to deliver radiotherapy to biologically active tumors. Giving BgRT may be safe and effective in treating patients with painful bone metastases.
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 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.
Interventions
- Procedure Computed Tomography
Undergo PET/CT - Radiation Image Guided Radiation Therapy
Undergo BgRT - Procedure Positron Emission Tomography
Undergo PET/CT - Other Questionnaire Administration
Ancillary studies
Primary outcome measures
- Incidence of adverse events [Time frame: Up to 1 year follow-up]
- Pain response [Time frame: Up to 1 year follow-up]
Secondary outcome measures (4)
- Rates of re-irradiation [Time frame: At 1 year follow-up]
- Radiographic evidence of disease progression [Time frame: Up to 1 year follow-up]
- Patient-reported health related quality of life (QOL) [Time frame: Up to 1 year follow-up]
- Incidence of clinician-related chronic toxic effects [Time frame: Up to 1 year follow-up]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- City of Hope Medical Center — Duarte
Identifiers
NCT: NCT06549478 · 23937 · NCI-2024-06473 · 23937 · P30CA033572