SMC Radiation Oncology SABR Cohort for Oligometastasis

NCT07121335 — Recruiting, 60 participants, Samsung Medical Center

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Cohort Study for Local Stereotactic Body Radiotherapy in Patients With Oligometastatic or Oligoprogressive Cancer

Registry	NCT07121335, acronym SABR-OMOP
Status	Recruiting
Study type	Observational
Enrollment	60 (Estimated)
Sponsor	Samsung Medical Center (Other)
Conditions	Stereotactic Body Radiation Therapy (SBRT), Oligometastasis, Oligoprogression, ctDNA, Patient-Reported Outcomes (PRO)
Interventions	Stereotactic body radiotherapy (SBRT) (Radiation)
Dates	start 2025-05-01, primary completion 2027-12-31 (estimated), completion 2030-03-31 (estimated), first posted 2025-08-13, last updated 2025-08-13
Locations	1 site in South Korea

-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. patient-reported outcomes,
3. physician-assessed toxicity, and
4. dynamics of circulating tumor DNA (ctDNA) for biomarker analysis.

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+Arms and interventions

Stereotactic body radiotherapy (SBRT) (Radiation): Stereotactic body radiotherapy (SABR) using photon or proton beams will be delivered per standard practice (1-5 fractions).

+Outcome measures

Primary outcomes

Progression-free survival [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 [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 [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 [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 [It will be collected 1-week before SABR and 4-6 weeks after SABR.]: ctDNA analysis

+Eligibility

Sex: All, ages: 18 Years to any

Inclusion Criteria:

* 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)

Exclusion Criteria:

* Patient with a history of prior radiotherapy to the site planned for SABR
* Patients with concomitant brain metastases

+Locations (1)

Facility	City	Country	Status
Samsung medical center	Seoul	South Korea	Recruiting