AzTrials
AzTrials

Metastatic Malignant Solid NeoplasmEarly Phase 1NCT05733949

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

A Early Phase 1 study testing Biospecimen Collection, Computed Tomography and Stereotactic Body Radiation Therapy in people with Metastatic Malignant Solid Neoplasm, run by City of Hope Medical Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Malignant Solid Neoplasm
What is being tested?
Biospecimen Collection, Computed Tomography and Stereotactic Body Radiation Therapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
27 Apr 2023to 11 Oct 2027
Phase
Early Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 11Show fewer
  • 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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting

  • City of Hope Medical Center

    Duarte, California, 91010

    Yi-Jen Chen, 626-218-4589, yichen@coh.org

    Yi-Jen Chen

    Recruiting

Other trials in United States

About this study

Official title: 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.

Read the detailed description

PRIMARY OBJECTIVE:

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

SECONDARY OBJECTIVES:

  1. 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.

  1. 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:

  1. 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.

Being tested
Biospecimen Collection, Computed Tomography, Stereotactic Body Radiation Therapy
Medical subject headings
Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Biospecimen CollectionProcedure or surgery

    Also called Biological Sample Collection, Biospecimen Collected, Specimen Collection

    Undergo collection of blood samples

  • Computed TomographyProcedure or surgery

    Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography

    Undergo CT

  • Stereotactic Body Radiation TherapyRadiation

    Also called SABR, SBRT, Stereotactic Ablative Body Radiation Therapy

    Undergo ST-SBRT

Study groups in NCT05733949
Study groupRoleWhat they receive
Treatment (ST-SBRT)ExperimentalPatients 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.
Receives: Procedure: Biospecimen Collection; Procedure: Computed Tomography; Radiation: Stereotactic Body Radiation Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events

    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.

    Measured: Within 3 months after the last spatiotemporal stereotactic body radiation therapy (ST-SBRT) fraction

  2. Effectiveness of ST-SBRT

    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.

    Measured: 4 weeks after any ST-SBRT fraction

Secondary outcomes (8)

  1. Screen failures

    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.

    Measured: Up to 1 year

  2. Number of ST-SBRT fractions received, per subject

    Will be described using summary statistics.

    Measured: Up to 1 year

  3. Number of treatment fractions that require adaptation

    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.

    Measured: Up to 1 year

  4. Percentage of subjects who experience abscopal effect

    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.

    Measured: 4 weeks after any ST-SBRT fraction

  5. Overall survival

    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.

    Measured: Up to 1 year post initiation of study treatment

  6. Change in quality of life

    Evaluated using the Functional Assessment in Cancer Therapy - General.

    Measured: From baseline to 3 months after initial fraction

  7. Change in volume (per lesion)

    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.

    Measured: Baseline through 3 months after the first treatment fraction

  8. Clinical response per fraction (per lesion)

    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.

    Measured: Baseline to after each treatment fraction (each cycle is 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2023
  2. Study start27 Apr 2023
  3. Primary completion11 Oct 2027 (estimated)
  4. Study completion11 Oct 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05733949
Sponsor's protocol ID
22277
Other IDs
NCI-2023-00245, 22277, P30CA033572
Status last verified
Aug 2026
First submitted
30 Jan 2023
Last updated
19 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing Biospecimen Collection, Computed Tomography and Stereotactic Body Radiation Therapy in people with Metastatic Malignant Solid Neoplasm, run by City of Hope Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (time frame: Within 3 months after the last spatiotemporal stereotactic body radiation therapy (ST-SBRT) fraction). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05733949.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in