Recruiting
Early Phase 1

Stereotactic Body Radiation Therapy

Sponsor:

City of Hope Medical Center

Code:

NCT05733949

Conditions

Metastatic Malignant Solid Neoplasm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Computed Tomography

Stereotactic Body Radiation Therapy

Study Details

Brief 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.

Conditions

Metastatic Malignant Solid Neoplasm

Study ID

NCT05733949

Start date

Apr 27, 2023

Status verified date

Aug, 2026

Completion date

Oct 11, 2027

Anticipated

Primary completion date

Oct 11, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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)

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (ST-SBRT)

Patients undergo ST-SBRT on study. Patients also undergo collection of blood samples at screening and on study and undergo CT at screening, on study, and during follow up.

Interventions

Biospecimen Collection

Undergo collection of blood samples

Computed Tomography

Undergo CT

Stereotactic Body Radiation Therapy

Undergo ST-SBRT

Primary outcome measure

  • Incidence of adverse events [ Time Frame: Within 3 months after the last spatiotemporal stereotactic body radiation therapy (ST-SBRT) fraction ]
  • Effectiveness of ST-SBRT [ Time Frame: 4 weeks after any ST-SBRT fraction ]

Central Contacts and Locations

Locations

City of Hope Medical Center

Recruiting

Duarte, California, United States, 91010

Contacts

Yi-Jen Chen

626-218-4589yichen@coh.org

Principal Investigator:

Yi-Jen Chen

More Information

Sponsor

City of Hope Medical Center

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by City of Hope Medical Center on 2026-08-19.