Spatiotemporal Stereotactic Body Radiation Therapy for the Treatment of Patients With Polymetastatic Solid Tumors
A Pilot Study of Spatiotemporal SBRT for Poly-Metastatic Cancer
City of Hope Medical Center
20 participants
Apr 27, 2023
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria11
- 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 Criteria7
- 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)
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Interventions
Undergo collection of blood samples
Undergo CT
Undergo ST-SBRT
Locations(1)
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NCT05733949