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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.

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Sites and contacts
Official record

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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
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.

Nalee Kim, MD, PhD contact

82-2-3410-2612

nalee.kim@samsung.com

South Korea1 site, 1 recruiting
  • Samsung medical center

    Seoul, 06351

    Nalee Kim, 82-2-3410-2612, nalee.kim@samsung.com

    Recruiting

Other trials in South Korea

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:

  1. oncologic outcomes (progression-free survival, local failure rate),
  2. patient-reported outcomes,
  3. physician-assessed toxicity, and
  4. dynamics of circulating tumor DNA (ctDNA) for biomarker analysis.
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.

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  1. First posted13 Aug 2025
  2. Study start1 May 2025
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Mar 2030 (estimated)

Resources

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
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

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