Biology-Guided Radiation Therapy for the Treatment of Patients With Bone Metastases
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorCity of Hope Medical Center
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Patients with prior radiation therapy to the treatment sites
Untreated spinal cord compression
Pathologic fracture at the evaluated site
Serious medical comorbidities precluding radiotherapy
Trial design
Design model
Single group
Treatments tested in this trial
Computed Tomography
Procedure/SurgeryUndergo PET/CT
Image Guided Radiation Therapy
RadiationUndergo BgRT
Positron Emission Tomography
Procedure/SurgeryUndergo PET/CT
Questionnaire Administration
Other interventionAncillary studies
Treatment groups
24 Participants
are divided into 1 treatment groupGroup A: Treatment (BgRT)Experimental treatment 4 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 1 year follow-up2
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.
Time frame
Up to 1 year follow-upSecondary outcomes
1
Rates of re-irradiation
Time frame
At 1 year follow-up2
Radiographic evidence of disease progression
Radiographic evidence of disease progression at treated sites will be assessed using imaging scans.
Time frame
Up to 1 year follow-up3
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.
Time frame
Up to 1 year follow-up4
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.
Time frame
Up to 1 year follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Source ClinicalTrials.gov