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NCT Number: NCT07121335

SMC Radiation Oncology SABR Cohort for Oligometastasis

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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Key information

Conditions

Stereotactic Body Radiation Therapy (SBRT) CtDNA Oligometastasis Oligoprogression Patient-Reported Outcomes (PRO)

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stereotactic body radiotherapy (SBRT)

Radiation

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

Primary outcomes

  1. 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.

  2. 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

  3. 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.

  4. 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.

  5. Dynamics of ctDNA

    Time frame: It will be collected 1-week before SABR and 4-6 weeks after SABR.

    ctDNA analysis

Study contacts

Contact information is provided by the study sponsor or research team.

Nalee Kim, MD, PhD

CONTACT

[email protected]

82-2-3410-2612

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Acronym: SABR-OMOP

Important dates

Study start
2025
Primary completion
2027
Study completion
2030
First posted
Aug 13, 2025
Registry last updated
Aug 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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