ctDNA, Oligometastasis, Oligoprogression, Patient-Reported Outcomes (PRO), Stereotactic Body Radiation Therapy (SBRT)
Conditions
Keywords
Stereotactic body radiotherapy, Oligometastasis, Oligoprogression, ctDNA
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.
Interventions
RADIATIONStereotactic body radiotherapy (SBRT)
Stereotactic body radiotherapy (SABR) using photon or proton beams will be delivered per standard practice (1-5 fractions).
Sponsors
Samsung Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
South Korea
Contacts
Primary ContactNalee Kim, MD, PhD
Outcome results
None listed