This clinical trial evaluates the safety and effectiveness of spatiotemporal stereotactic body radiation therapy (ST-SBRT) in treating patients with solid tumors that have spread to other parts of the body (polymetastatic). SBRT uses special equipment to position a patient and deliver radiation to tumors with high precision. This method may kill tumor cells with fewer doses over a shorter period and cause less damage to normal tissue. ST-SBRT is designed to deliver radiation directly to the core of the tumor, while keeping the radiation exposure of the area around the tumor at minimal dosage.
Documented informed consent of the participant and/or legally authorized representative
Assent, when appropriate, will be obtained per institutional guidelines
Age: >= 18 years
Karnofsky performance status > 60
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
Those not eligible for SBRT after review by a radiation oncologist
Serous medical comorbidities precluding radiotherapy
Unable to undergo a CT scan
Single group
Biospecimen Collection
Procedure/SurgeryUndergo collection of blood samples
Computed Tomography
Procedure/SurgeryUndergo CT
Stereotactic Body Radiation Therapy
RadiationUndergo ST-SBRT
Incidence of adverse events
Toxicity is defined as non-hematologic toxicity that is at least grade 3 (Common Terminology Criteria for Adverse Events version \[v\]5.0) and at least possibly related to the study treatment.
Effectiveness of ST-SBRT
Efficacy (corresponding to local treatment effect) is defined as a complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 within an irradiated lesion, as detected by computed tomography (CT) scan 4 weeks after any ST-SBRT fraction and compared against the baseline CT scan performed prior to any study treatment.
Screen failures
Defined as an eligible, consenting subject in whom guidelines indicate that a first fraction of ST-SBRT cannot be safely given or who withdraws consent before treatment. The percentage of eligible subjects who are screen failures will be described using summary statistics.
Number of ST-SBRT fractions received, per subject
Will be described using summary statistics.
Number of treatment fractions that require adaptation
Includes adaptation to align the 10 Gy isodose line to the center of the target and limit dose to 3 Gy at the periphery. Will be described using summary statistics.
Percentage of subjects who experience abscopal effect
Defined as CR or PR per RECIST v1.1 within a non-irradiated lesion, as detected by CT scan 4 weeks after any ST-SBRT fraction.
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City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
