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

August 18, 2026 updated by: City of Hope Medical Center

A Pilot Study of Spatiotemporal SBRT for Poly-Metastatic Cancer

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

PRIMARY OBJECTIVE:

I. To conduct a first evaluation of the toxicity and efficacy of ST-SBRT, targeting polymetastatic lesions as small as 2.0 cm.

SECONDARY OBJECTIVES:

I. To describe feasibility using:

Ia. Percentage of patients with screen failure; Ib. Number of ST-SBRT fractions given per subject; Ic. Percentage of treatment fractions that require adaptation.

II. To summarize:

IIa. Percentage of subjects with clinical response in non-irradiated lesions (abscopal effect); IIb. Duration of earliest clinical response; IIc. Frequency of late toxicity; IId. 1-year overall survival; IIe. 3-month change in total tumor volume; IIf. 3-month change in quality of life per Functional Assessment of Cancer Therapy (FACT)-General (G).

III. To evaluate whether a lesion's irradiation status is associated with its change in volume after 4 weeks.

IV. To compare alternate guidelines (Immune-Modified Response Evaluation Criteria in Solid Tumors [iRECIST], Immune-related Response Evaluation Criteria In Solid Tumors [irRECIST], Positron Emission Tomography [PET] Response Criteria in Solid Tumors [PERCIST]) against Response Evaluation Criteria in Solid Tumors (RECIST) version (v)1.1 for ability to detect clinical response in irradiated and non-irradiated lesions.

V. To evaluate whether, at 3 months after first treatment fraction, the net change in total tumor volume is associated with net change in quality of life (FACT-G).

EXPLORATORY OBJECTIVE:

I. To identify serologic markers correlated with net change in lesion volume.

OUTLINE:

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope Medical Center
        • Contact:
        • Principal Investigator:
          • Yi-Jen Chen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Procedure: Biospecimen Collection
Undergo collection of blood samples
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection
Procedure: Computed Tomography
Undergo CT
Other Names:
  • CT
  • CAT
  • CAT Scan
  • Computed Axial Tomography
  • Computerized Axial Tomography
  • Computerized Tomography
  • CT Scan
  • tomography
Radiation: Stereotactic Body Radiation Therapy
Undergo ST-SBRT
Other Names:
  • SBRT
  • SABR
  • Stereotactic Ablative Body Radiation Therapy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: Within 3 months after the last spatiotemporal stereotactic body radiation therapy (ST-SBRT) fraction
Toxicity is defined as non-hematologic toxicity that is at least grade 3 (Common Terminology Criteria for Adverse Events version [v]5.0) and at least possibly related to the study treatment.
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
Efficacy (corresponding to local treatment effect) is defined as a complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 within an irradiated lesion, as detected by computed tomography (CT) scan 4 weeks after any ST-SBRT fraction and compared against the baseline CT scan performed prior to any study treatment.
4 weeks after any ST-SBRT fraction

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Screen failures
Time Frame: Up to 1 year
Defined as an eligible, consenting subject in whom guidelines indicate that a first fraction of ST-SBRT cannot be safely given or who withdraws consent before treatment. The percentage of eligible subjects who are screen failures will be described using summary statistics.
Up to 1 year
Number of ST-SBRT fractions received, per subject
Time Frame: Up to 1 year
Will be described using summary statistics.
Up to 1 year
Number of treatment fractions that require adaptation
Time Frame: Up to 1 year
Includes adaptation to align the 10 Gy isodose line to the center of the target and limit dose to 3 Gy at the periphery. Will be described using summary statistics.
Up to 1 year
Percentage of subjects who experience abscopal effect
Time Frame: 4 weeks after any ST-SBRT fraction
Defined as CR or PR per RECIST v1.1 within a non-irradiated lesion, as detected by CT scan 4 weeks after any ST-SBRT fraction.
4 weeks after any ST-SBRT fraction
Overall survival
Time Frame: Up to 1 year post initiation of study treatment
The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive. In a clinical trial, measuring the overall survival is one way to see how well a new treatment works.
Up to 1 year post initiation of study treatment
Change in quality of life
Time Frame: From baseline to 3 months after initial fraction
Evaluated using the Functional Assessment in Cancer Therapy - General.
From baseline to 3 months after initial fraction
Change in volume (per lesion)
Time Frame: Baseline through 3 months after the first treatment fraction
The intervention's effect over time on net change in each lesion's volume relative to pre-treatment baseline will be investigated using a linear mixed model.
Baseline through 3 months after the first treatment fraction
Clinical response per fraction (per lesion)
Time Frame: Baseline to after each treatment fraction (each cycle is 28 days)
Evaluated using RECIST v1.1, Immune-Modified RECIST (iRECIST), Immune-Related RECIST (irRECIST), and Positron Emission Tomography Response Criteria in Solid Tumors (PERCIST). Three alternate guidelines (iRECIST, irRECIST, and PERCIST) will be compared to RECIST v1.1 on their ability to detect clinical response 4 weeks after a fraction of ST-SBRT, using a repeated measures logistic regression model fit by generalized estimating equation model.
Baseline to after each treatment fraction (each cycle is 28 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
City of Hope Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Cancer Institute (NCI)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yi-Jen Chen, City of Hope Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 27, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 11, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 11, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 15, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 17, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 19, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 22277 (Other Identifier: City of Hope Medical Center)
  • P30CA033572 (U.S. NIH Grant/Contract)
  • NCI-2023-00245 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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