← Back to all trials
Not Yet Recruiting
NCT05733949
Spatiotemporal Stereotactic Body Radiation Therapy for the Treatment of Patients With Polymetastatic Solid Tumors
Conditions: Metastatic Malignant Solid Neoplasm
Sex: All
Ages: 18 Years – N/A
Phase: NA
Enrollment: 20
Sponsor: City of Hope Medical Center
Location: United States
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 Criteria
Inclusion Criteria:Documented informed consent of the participant and/or legally authorized representativeAssent, when appropriate, will be obtained per institutional guidelinesAge: >= 18 yearsKarnofsky performance status > 60Poly-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 therapyPre-screening assessment confirms that the intervention can be administered without exceeding dose constraint guidelinesPatients 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 findingsSpinal cord metastases are allowed as long as treatment with or without radiation is completedPrior radiotherapy in general is allowed, as long as the composite plan meets dose constraintsLife expectancy >= 3 months in the opinion of the treating investigatorsOff systemic therapy for at least one month prior and one month after study interventionExclusion 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 requirementsThose not eligible for SBRT after review by a radiation oncologistSerous medical comorbidities precluding radiotherapyUnable to undergo a CT scanPregnant 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 therapyOn active systemic therapyProspective 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)
Source: ClinicalTrials.gov (NCT05733949). StuddyBuddy aggregates publicly available trial information.