Stereotactic Body Radiation Therapy (SBRT)SABR-OMOPNCT07121335
SMC Radiation Oncology SABR Cohort for Oligometastasis
An observational study of Stereotactic Body Radiation Therapy (SBRT) and Oligometastasis, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The goal of this observational study is to evaluate the efficacy and safety of stereotactic body radiotherapy (SABR) in patients with oligometastatic or oligoprogressive cancer. The main questions it aims to answer are: 1. oncologic outcomes (progression-free survival, local failure rate), 2. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stereotactic Body Radiation Therapy (SBRT), Oligometastasis, Oligoprogression
- What is being tested?
- Stereotactic body radiotherapy (SBRT)
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 May 2025to 31 Mar 2030
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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
Study population: Cancer patients who are Confirmed to have oligometastatic/oligoprogressive cancer on imaging performed within 4 weeks (up to 5 lesions)
Who may be able to join
- Performance status (ECOG PS) 0-2
- Diagnosed with metastatic disease
- Confirmed to have oligometastatic/oligoprogressive cancer on imaging performed within 4 weeks (up to 5 lesions)
Who cannot join
- Patient with a history of prior radiotherapy to the site planned for SABR
- Patients with concomitant brain metastases
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Samsung medical center
Seoul, 06351
Nalee Kim, 82-2-3410-2612, nalee.kim@samsung.com
About this study
Official title: Cohort Study for Local Stereotactic Body Radiotherapy in Patients With Oligometastatic or Oligoprogressive Cancer
The goal of this observational study is to evaluate the efficacy and safety of stereotactic body radiotherapy (SABR) in patients with oligometastatic or oligoprogressive cancer.
The main questions it aims to answer are:
- oncologic outcomes (progression-free survival, local failure rate),
- patient-reported outcomes,
- physician-assessed toxicity, and
- dynamics of circulating tumor DNA (ctDNA) for biomarker analysis.
- Conditions
- Stereotactic Body Radiation Therapy (SBRT), Oligometastasis, Oligoprogression, ctDNA, Patient-Reported Outcomes (PRO)
- Being tested
- Stereotactic body radiotherapy (SBRT)
- Keywords
- Stereotactic body radiotherapy, Oligometastasis, Oligoprogression, ctDNA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stereotactic body radiotherapy (SBRT)Radiation
Stereotactic body radiotherapy (SABR) using photon or proton beams will be delivered per standard practice (1-5 fractions).
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival
Time from the start of stereotactic body radiotherapy (SABR) to the first documented event of local failure, distant failure, death from any cause, or last follow-up, whichever occurs first.
Measured: From start of SABR to the earliest of local failure, distant failure, death, or last follow-up. It will be measured at 1 month after completion of SABR, and at 6 months, 1 year, 2 years, and 3 years after SABR.
Physician assessed toxicity
Evaluated by treating physician based on CTCAE ver 5.0
Measured: 1 month after completion of SABR, and at 6 months, 1 year, 2 years, and 3 years after SABR.
Patient-reported outcome
It will be measured by PRO-CTCAE coreset 12.
Measured: 1 month after completion of SABR, and at 6 months, 1 year, 2 years, and 3 years after SABR.
Local failure
Local regrowth or progression at the site of SABR.
Measured: 1 month after completion of SABR, and at 6 months, 1 year, 2 years, and 3 years after SABR.
Dynamics of ctDNA
ctDNA analysis
Measured: It will be collected 1-week before SABR and 4-6 weeks after SABR.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start1 May 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stereotactic Body Radiation Therapy (SBRT)Studies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nalee Kim, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121335
- Sponsor's protocol ID
- SMC 2025-03-037
- Acronym
- SABR-OMOP
- Status last verified
- Aug 2025
- First submitted
- 4 Aug 2025
- Last updated
- 13 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cohort Study for Local Stereotactic Body Radiotherapy in Patients With Oligometastatic or Oligoprogressive Cancer
- ClinicalTrials.gov ID
- NCT07121335
- Acronym / sponsor ID
- SABR-OMOP / SMC 2025-03-037
- Conditions
- Stereotactic Body Radiation Therapy (SBRT), Oligometastasis, Oligoprogression, ctDNA, Patient-Reported Outcomes (PRO)
- Keywords
- Stereotactic body radiotherapy, Oligometastasis, Oligoprogression, ctDNA
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational study is to evaluate the efficacy and safety of stereotactic body radiotherapy (SABR) in patients with oligometastatic or oligoprogressive cancer.
The main questions it aims to answer are:
- oncologic outcomes (progression-free survival, local failure rate),
- patient-reported outcomes,
- physician-assessed toxicity, and
- dynamics of circulating tumor DNA (ctDNA) for biomarker analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patients who are Confirmed to have oligometastatic/oligoprogressive cancer on imaging performed within 4 weeks (up to 5 lesions)
Key inclusion criteria (3 listed)
- Performance status (ECOG PS) 0-2
- Diagnosed with metastatic disease
- Confirmed to have oligometastatic/oligoprogressive cancer on imaging performed within 4 weeks (up to 5 lesions)
Key exclusion criteria (2 listed)
- Patient with a history of prior radiotherapy to the site planned for SABR
- Patients with concomitant brain metastases
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 body radiotherapy (SBRT)Stereotactic body radiotherapy (SABR) using photon or proton beams will be delivered per standard practice (1-5 fractions). | Radiation | – |
Primary outcome
Progression-free survival
Time frame: From start of SABR to the earliest of local failure, distant failure, death, or last follow-up. It will be measured at 1 month after completion of SABR, and at 6 months, 1 year, 2 years, and 3 years after SABR.
Time from the start of stereotactic body radiotherapy (SABR) to the first documented event of local failure, distant failure, death from any cause, or last follow-up, whichever occurs first.
Physician assessed toxicity
Time frame: 1 month after completion of SABR, and at 6 months, 1 year, 2 years, and 3 years after SABR.
Evaluated by treating physician based on CTCAE ver 5.0
Patient-reported outcome
Time frame: 1 month after completion of SABR, and at 6 months, 1 year, 2 years, and 3 years after SABR.
It will be measured by PRO-CTCAE coreset 12.
Local failure
Time frame: 1 month after completion of SABR, and at 6 months, 1 year, 2 years, and 3 years after SABR.
Local regrowth or progression at the site of SABR.
Dynamics of ctDNA
Time frame: It will be collected 1-week before SABR and 4-6 weeks after SABR.
ctDNA analysis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stereotactic Body Radiation Therapy (SBRT) and Oligometastasis, run by Samsung Medical Center at 1 site in South Korea.
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 3 inclusion and 2 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 13 Aug 2025. 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 South Korea. 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?
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?
Contact Nalee Kim, MD, PhD (82-2-3410-2612, nalee.kim@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (time frame: From start of SABR to the earliest of local failure, distant failure, death, or last follow-up. It will be measured at 1 month after completion of SABR, and at 6 months, 1 year, 2 years, and 3 years after SABR.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Aug 2025.