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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

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
NameTimeMethod
Progression-free survivalFrom 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 toxicity1 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 outcome1 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 failure1 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 ctDNAIt will be collected 1-week before SABR and 4-6 weeks after SABR.

ctDNA analysis

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Samsung medical center

🇰🇷

Seoul, Korea, Republic of

Samsung medical center
🇰🇷Seoul, Korea, Republic of
Nalee Kim
Contact
82-2-3410-2612
nalee.kim@samsung.com

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