Using advanced radiation therapy to treat patients with multiple metastatic tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and effectiveness of spatiotemporal stereotactic body radiation therapy (ST-SBRT) for patients with polymetastatic solid tumors. The approach involves delivering high-precision radiation directly to tumor cores while minimizing exposure to surrounding healthy tissue. The study aims to assess various outcomes, including clinical response, toxicity, and quality of life changes, while also exploring the feasibility of the treatment. Additionally, it will compare different response evaluation criteria to determine the most effective methods for assessing treatment response.

Why it matters

Who can join: the full rules

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)

Where it's running

• City of Hope Medical Center
  Duarte, California, United States Recruiting

Study contacts

• Principal investigator: Yi-Jen Chen — City of Hope Medical Center

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.