NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

RecruitingEARLY_Phase 1

Sponsor: City of Hope Medical Center

Conditions: Metastatic Malignant Solid Neoplasm

Interventions: Biospecimen Collection, Computed Tomography, Stereotactic Body Radiation Therapy

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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)

Locations (1)

Duarte, California, United States