RECRUITING Early Phase 1 ClinicalTrials.gov

Spatiotemporal Stereotactic Body Radiation Therapy for the Treatment of Patients With Polymetastatic Solid Tumors

Sponsor: City of Hope Medical Center • ClinicalTrials.gov ID: NCT05733949

Registry updated: 2026-08-19

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Description

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.

Interventions

Biospecimen Collection (Procedure)
Undergo collection of blood samples
Computed Tomography (Procedure)
Undergo CT
Stereotactic Body Radiation Therapy (Radiation)
Undergo ST-SBRT

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 * Karnofsky performance status \> 60 * Poly-metastatic disease, \> 5 lesions, and with at least one lesion \> 2.0 cm, with limited treatment options, and ineligible for or in progression under the standard systemic therapy * 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 * Spinal cord metastases are allowed as long as treatment with or without radiation is completed * Prior radiotherapy in general is allowed, as long as the composite plan meets dose constraints * Life expectancy \>= 3 months in the opinion of the treating investigators * Off systemic therapy for at least one month prior and one month after study intervention Exclusion Criteria: * 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 * Pregnant and/or breastfeeding women are excluded from this study as these agents may have the potential for teratogenic or abortifacient effects. Female patients of childbearing potentially must have a negative urine or serum pregnancy test within 72 hours prior to receiving therapy * On active systemic therapy * 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)

Conditions

Metastatic Malignant Solid Neoplasm

Locations

City of Hope Medical Center — Duarte, California, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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