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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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stereotactic body radiotherapy (SBRT) | Radiation | Stereotactic body radiotherapy (SABR) using photon or proton beams will be delivered per standard practice (1-5 fractions). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Cancer patients who are Confirmed to have oligometastatic/oligoprogressive cancer on imaging performed within 4 weeks (up to 5 lesions)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nalee Kim, MD, PhD | Contact | 82-2-3410-2612 | nalee.kim@samsung.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung medical center | Recruiting | Seoul | 06351 | South Korea |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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Whole blood (20 mL) will be collected and retained for future DNA extraction and biomarker analyses, including circulating tumor DNA (ctDNA) profiling.
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |