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

RECRUITINGN/ASponsored by City of Hope Medical Center
Actively Recruiting
PhaseN/A
SponsorCity of Hope Medical Center
Started2023-04-27
Est. completion2027-10-11
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site

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

Age: 18 Years+Healthy volunteers accepted
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)

Conditions2

CancerMetastatic Malignant Solid Neoplasm

Locations1 site

City of Hope Medical Center
Duarte, California, 91010
Yi-Jen Chen626-218-4589yichen@coh.org

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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