SMC Radiation Oncology SABR Cohort for Oligometastasis

NCT07121335 | Recruiting

• 1 other identifier: SMC 2025-03-037
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

Stereotactic body radiotherapy; Oligometastasis; Oligoprogression; ctDNA

Outcome Measures

Primary Outcomes (5)

• 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.

  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

  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.

  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.

  1 month after completion of SABR, and at 6 months, 1 year, 2 years, and 3 years after SABR.

• Dynamics of ctDNA

  ctDNA analysis

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

Interventions

Stereotactic body radiotherapy (SBRT) RADIATION

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Cancer patients who are Confirmed to have oligometastatic/oligoprogressive cancer on imaging performed within 4 weeks (up to 5 lesions)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung medical center

Seoul, 06351, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood (20 mL) will be collected and retained for future DNA extraction and biomarker analyses, including circulating tumor DNA (ctDNA) profiling.

MeSH Terms

Interventions

Radiosurgery

Intervention Hierarchy (Ancestors)

Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Central Study Contacts

Nalee Kim, MD, PhD

CONTACT

82-2-3410-2612; nalee.kim@samsung.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 13, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): March 31, 2030
• Last Updated: August 13, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)