SMC Radiation Oncology SABR Cohort for Oligometastasis
- Conditions
- Stereotactic Body Radiation Therapy (SBRT)OligometastasisPatient-Reported Outcomes (PRO)OligoprogressionctDNA
- 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
- 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)
- 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Samsung medical center
🇰🇷Seoul, Korea, Republic of
Samsung medical center🇰🇷Seoul, Korea, Republic ofNalee KimContact82-2-3410-2612nalee.kim@samsung.com