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
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