Biology-Guided Radiation Therapy for the Treatment of Patients With Bone Metastases
NCT Number: NCT06549478
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Metastatic Malignant Neoplasm in the Bone|Metastatic Malignant Solid Neoplasm
Interventions: PROCEDURE: Computed Tomography|RADIATION: Image Guided Radiation Therapy|PROCEDURE: Positron Emission Tomography|OTHER: Questionnaire Administration
Sponsor: City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-07-26
Completion Date: 2027-01-26
Locations: City of Hope Medical Center, Duarte, California, 91010, United States

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.

Primary Outcome Measures: Incidence of adverse events, Adverse events will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0. Toxicity is defined as any ≥ grade 3 gastrointestinal, genitourinary, lung, or skeletomuscular toxicities that is considered at least possibly related to the study treatment and occurs within 3 months after the treatment., Up to 1 year follow-up|Pain response, Will be assessed using international consensus endpoints assessing a combination of pain severity and analgesic consumption. Pain progression reflects either (a) an increase in a worst-pain score of 2 or more without reduced daily morphine milligram equivalent (MME), or (b) no change in worst-pain score or 1 point above baseline and an increase in daily MME of at least 25%. Indeterminate response then indicates all other responses. Overall response is defined as sum of complete response and partial response at 3 months after single fraction-biology-guided radiation therapy., Up to 1 year follow-up
Secondary Outcome Measures: Rates of re-irradiation, At 1 year follow-up|Radiographic evidence of disease progression, Radiographic evidence of disease progression at treated sites will be assessed using imaging scans., Up to 1 year follow-up|Patient-reported health related quality of life (QOL), QOL will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Bone Metastases Module., Up to 1 year follow-up|Incidence of clinician-related chronic toxic effects, Toxicity is defined as any ≥ grade 3 gastrointestinal, genitourinary, lung, or skeletomuscular toxicities that is considered at least possibly related to the study treatment and occurs within 3 months after the treatment. Clinician-related chronic toxic effects will be assessed using the Common Terminology Criteria for Adverse Events version 5.0., Up to 1 year follow-up