SMC Radiation Oncology SABR Cohort for Oligometastasis

Recruiting

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

• Registration Number: NCT07121335
• Lead Sponsor: Samsung Medical Center

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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-05-01
• Status Verified: 2025-08
• Study First Submitted: 2025-08-04
• Study First Submitted QC: 2025-08-08
• Last Update Submitted: 2025-08-08
• Study First Posted: 2025-08-13
• Last Update Posted: 2025-08-13
• Primary Completion: 2027-12-31
• Study Completion: 2030-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Samsung medical center; 🇰🇷 Seoul, Korea, Republic of