Biology-Guided Radiation Therapy for the Treatment of Patients With Bone Metastases
Start Date
7/26/2024
Completion Date
1/26/2027
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 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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Computed Tomography
Image Guided Radiation Therapy
Positron Emission Tomography
Questionnaire Administration
Conditions
Locations
City of Hope Medical Center
Duarte, California 91010
United States