Metastatic CarcinomaSMART ONENCT04939246
Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) in One Fraction
A study testing Stereotactic ablative body radiation therapy in people with Metastatic Carcinoma, run by Baptist Health South Florida at 2 sites in United States.
Trial summary
This is a multi-site single arm feasibility study of single-fraction Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) for primary or metastatic carcinoma involving the lung, liver, adrenal gland, abdominal/pelvic lymph node, pancreas, and/or kidney. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Carcinoma
- What is being tested?
- Stereotactic ablative body radiation therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesUnited States
- Study dates
- 18 Jun 2021to 17 Jul 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Subject must be ≥18 years of age at the time of study enrollment
- Subject must have Biopsy-confirmed primary or metastatic carcinoma with involvement of the lung, liver, adrenal gland, pancreas, kidney, and/or abdominal/pelvic lymph node that would receive SABR
- Any lesion that would receive SABR under this study protocol is no larger than 5 cm in greatest dimension
- 1-10 total lesions that would receive SABR
- If multiple lesions are treated, they must be at least 3 cm apart
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
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- Life expectancy at least 6 months
- Women of childbearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control) prior to study entry and for the duration of study participation. Abstinence is acceptable if it's the patient preferred method. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
- Patients receiving hormonal therapy or immunotherapy such as immune checkpoint inhibitor that had begun at least 4 weeks prior to SABR will be allowed.
Who cannot join
- Subject has contraindication to having an MRI scan
- Subject has central or ultra-central lung tumor that would receive SABR on this study, defined as a lesion located within 2 cm of the trachea and proximal bronchial tree
- Subject has received cytotoxic chemotherapy or investigational agent within 2 weeks of SBRT
- Subject has uncontrolled brain metastases, spinal cord compression, or leptomeningeal carcinomatosis
- Subject has any unresolved toxicity (Common Terminology Criteria for Adverse Events version 5.0 > grade 2) from previous anti-cancer therapy
- Subject has any condition in the opinion of the investigator that would interfere with evaluation of study treatment or interpretation of patient safety or study results
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- Subject has received prior radiation therapy that directly overlaps any radiation therapy given in this study
- Subject has received radiation therapy that could lead to an unacceptably high risk of clinically significant normal tissue injury due to high cumulative normal tissue dose as determined by the investigator
- Female subject who are pregnant or breastfeeding
- Subject who has received vascular endothelial growth factor (VEGF) inhibitor such as bevacizumab within 4 weeks prior to study therapy or planned to receive it within 4 weeks after study therapy.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53717
Miami Cancer Institute at Baptist Health South Florida
Miami, Florida, 33176
About this study
Official title: A Feasibility Study of Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) in One Fraction for Inoperable Primary or Metastatic Carcinoma (SMART ONE)
This is a multi-site single arm feasibility study of single-fraction Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) for primary or metastatic carcinoma involving the lung, liver, adrenal gland, abdominal/pelvic lymph node, pancreas, and/or kidney. Stereotactic ablative body radiation therapy (SABR) is a highly-focused radiation treatment that gives an intense dose of radiation concentrated on a tumor, while limiting the dose to the surrounding organs.
- Conditions
- Metastatic Carcinoma
- Being tested
- Stereotactic ablative body radiation therapy
- Medical subject headings
- Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic ablative body radiation therapyRadiation
Single-fraction of stereotactic ablative body radiation (SABR) therapy will be delivered with an integrated magnetic resonance imaging (MRI)-guided radiotherapy delivery system (ViewRay MRIdian Linac). The prescription dose is dependent on the anatomic location of the lesion and based on previously published safety data.
| Study group | Role | What they receive |
|---|---|---|
| Single-fraction SABR | Other | Patients will receive SABR in a single-fraction regiment treatment with one single dose of radiation therapy per lesion. Patients may be treated for up to a total of ten lesions. Each lesion will be treated in one fraction. Receives: Radiation: Stereotactic ablative body radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With SABR Successfully Delivered in One Fraction
To be considered successful, SABR treatment must meet the following criteria:
- Successful completion of treatment to each lesion within 3 days of intended treatment date
- Successful completion of treatment to each lesion within 90 minutes from the patient entering the treatment room until treatment completion for at least 80% of treated lesions
- Image guidance verification of treatment delivery within 5 mm of the planned delivery
Measured: through study completion, an average of 1 year
Number of Patients Demonstrating Tolerability
Number of patients that meet the following criteria:
- No greater than 4 of 30 patients experience grade 3 or higher acute toxicity is attributable to SABR within 90 days of completing SABR
- No grade 5 toxicity is attributed to SABR
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
One-year Local Control
Assessed using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and estimated with Kaplan-Meier and corresponding 95% confidence interval from the time of study treatment.
Target lesion:
- Complete response (CR): Disappearance of all target lesions
- Partial response (PR): >30% decrease in the sum of the diameters of target lesions
- Stable disease (SD): Target lesion has neither sufficient decrease to qualify as a PR or sufficient increase to qualify as progressive disease (PD)
- PD: At least a 20% increase in the sum of the diameters of target lesions an absolute increase of at least 5 mm
Non-target lesion:
- CR: Disappearance of all non-target lesions
- SD: Persistence of ≥1 non-target lesions
- PD: Appearance of ≥1 new lesions or unequivocal progression of existing non-target lesions
Overall:
- CR: Target CR+non-target CR
- PR: Target CR/PR+non-target non-PD
- SD: Target SD+non-target non-PD
- PD: Anything else
Local control=CR+PR+SD using overall response.
Measured: 12 months
Percent of Participants With One-year Overall Survival
Percent of participants with one-year overall survival will be estimated using the Kaplan-Meier method along with the corresponding 95% confidence interval from the time of study treatment.
Measured: 12 months
Number of Participants With Acute and Late Toxicity Results
Number of participants with acute and late toxicities defined as grade 3 or higher toxicity attributable to SABR will be determined. For patients receiving SABR to multiple lesions, acute toxicity will be determined from the date of the initiation of SABR.
Measured: 12 months
Change in Participant Reported Quality of Life Questionnaire
Patient-reported quality of life will be determined using the Functional Assessment of Cancer Therapy - General (FACT-G) survey instrument. FACT-G is a 27-item questionnaire that covers four sub-domains: physical (7 items), social (7 items), emotional, (6 items), and functional (7 items) well-being. Each question is scored from a scale from 0 (not at all) to 4 (very much) using a manual scoring template in which some items are reversed. After reversal of specified items, the sub-domain scores are totaled, then multiplied by the number of items in the sub-domain, and then divided by the number of items the participant answered. The scores for each sub-domain are 0 (worst well-being) to 24 (best emotional well-being) or 28 (best physical, social, or functional well-being). The total scores can range from 0 (worst overall well-being) to 108 (best overall well-being).
Measured: baseline, 3, 6, 9, and 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2021
- Study start18 Jun 2021
- Primary completion17 Jul 2024
- Study completion17 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metastatic CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baptist Health South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Viewray Inc.
- Responsible party
- Sponsor
- Investigators
- Michael Chuong, MD, Principal investigator, Miami Cancer Institute (MCI) at Baptist Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04939246
- Sponsor's protocol ID
- 2020-CHU-002
- Acronym
- SMART ONE
- Status last verified
- Apr 2025
- First submitted
- 10 Jun 2021
- Last updated
- 17 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Chuong MD, Mittauer KE, Bassetti MF, Rojas C, Glide-Hurst C, Kalman NS, Tom MC, Rubens M, Crosby J, Burr A, Tolakanahalli R, Gutierrez AN, Bassiri N, Mehta MP, Kotecha R. Stereotactic Magnetic Resonance Guided Adaptive Radiation Therapy in One Fraction (SMART ONE): A Multicenter, Single-Arm, Phase 2 Trial. Int J Radiat Oncol Biol Phys. 2025 Jul 15;122(4):957-967. doi: 10.1016/j.ijrobp.2025.03.030. Epub 2025 Mar 28.
PubMed 40158734
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) in One Fraction for Inoperable Primary or Metastatic Carcinoma (SMART ONE)
- ClinicalTrials.gov ID
- NCT04939246
- Acronym / sponsor ID
- SMART ONE / 2020-CHU-002
- Conditions
- Metastatic Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Baptist Health South FloridaUniversity, hospital or other
- Collaborators
- Viewray Inc.
- Study start
- 18 Jun 2021 (actual)
- Primary completion
- 17 Jul 2024 (actual)
- Study completion
- 17 Jul 2024 (actual)
- First posted
- 25 Jun 2021 (actual)
- Results
- Posted 17 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multi-site single arm feasibility study of single-fraction Stereotactic MRI-guided Adaptive Radiation Therapy (SMART) for primary or metastatic carcinoma involving the lung, liver, adrenal gland, abdominal/pelvic lymph node, pancreas, and/or kidney. Stereotactic ablative body radiation therapy (SABR) is a highly-focused radiation treatment that gives an intense dose of radiation concentrated on a tumor, while limiting the dose to the surrounding organs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-fraction SABR | Other | Radiation: Stereotactic ablative body radiation therapyPatients will receive SABR in a single-fraction regiment treatment with one single dose of radiation therapy per lesion. Patients may be treated for up to a total of ten lesions. Each lesion will be treated in one fraction. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject must be ≥18 years of age at the time of study enrollment
- Subject must have Biopsy-confirmed primary or metastatic carcinoma with involvement of the lung, liver, adrenal gland, pancreas, kidney, and/or abdominal/pelvic lymph node that would receive SABR
- Any lesion that would receive SABR under this study protocol is no larger than 5 cm in greatest dimension
- 1-10 total lesions that would receive SABR
- If multiple lesions are treated, they must be at least 3 cm apart
Key exclusion criteria (10 listed)
- Subject has contraindication to having an MRI scan
- Subject has central or ultra-central lung tumor that would receive SABR on this study, defined as a lesion located within 2 cm of the trachea and proximal bronchial tree
- Subject has received cytotoxic chemotherapy or investigational agent within 2 weeks of SBRT
- Subject has uncontrolled brain metastases, spinal cord compression, or leptomeningeal carcinomatosis
- Subject has any unresolved toxicity (Common Terminology Criteria for Adverse Events version 5.0 > grade 2) from previous anti-cancer therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stereotactic ablative body radiation therapySingle-fraction of stereotactic ablative body radiation (SABR) therapy will be delivered with an integrated magnetic resonance imaging (MRI)-guided radiotherapy delivery system (ViewRay MRIdian Linac). The prescription dose is dependent on the anatomic location of the lesion and based on previously published safety data. | Radiation | Single-fraction SABR |
Primary outcome
Number of Participants With SABR Successfully Delivered in One Fraction
Time frame: through study completion, an average of 1 year
To be considered successful, SABR treatment must meet the following criteria: 1. Successful completion of treatment to each lesion within 3 days of intended treatment date 2. Successful completion of treatment to each lesion within 90 minutes from the patient entering the treatment room until treatment completion for at least 80% of treated lesions 3. Image guidance verification of treatment delivery within 5 mm of the planned delivery
Number of Patients Demonstrating Tolerability
Time frame: through study completion, an average of 1 year
Number of patients that meet the following criteria: 1. No greater than 4 of 30 patients experience grade 3 or higher acute toxicity is attributable to SABR within 90 days of completing SABR 2. No grade 5 toxicity is attributed to SABR
4 secondary outcomes
One-year Local Control
Time frame: 12 months
Percent of Participants With One-year Overall Survival
Time frame: 12 months
Number of Participants With Acute and Late Toxicity Results
Time frame: 12 months
Change in Participant Reported Quality of Life Questionnaire
Time frame: baseline, 3, 6, 9, and 12 months after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 40158734Chuong MD, Mittauer KE, Bassetti MF, Rojas C, Glide-Hurst C, Kalman NS, Tom MC, Rubens M, Crosby J, Burr A, Tolakanahalli R, Gutierrez AN, Bassiri N, Mehta MP, Kotecha R. Stereotactic Magnetic Resonance Guided Adaptive Radiation Therapy in One Fraction (SMART ONE): A Multicenter, Single-Arm, Phase 2 Trial. Int J Radiat Oncol Biol Phys. 2025 Jul 15;122(4):957-967. doi: 10.1016/j.ijrobp.2025.03.030. Epub 2025 Mar 28.
- MCI - WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Chuong, MD principal investigator
Miami Cancer Institute (MCI) at Baptist Health, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stereotactic ablative body radiation therapy in people with Metastatic Carcinoma, run by Baptist Health South Florida at 2 sites 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 9 inclusion and 10 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: finished, as of the sponsor's last update on 17 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With SABR Successfully Delivered in One Fraction (time frame: through study completion, an average of 1 year). 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 NCT04939246, which also lists 1 linked publication.
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 17 Jul 2025.