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| Name | Class |
|---|---|
| SMG-SNU Boramae Medical Center | OTHER |
| Saint Vincent's Hospital, Korea | OTHER |
| Seoul National University Hospital | OTHER |
| Chungnam National University Hospital |
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Recently, MD Anderson Cancer Center reported the phase II trial to investigate high-dose radiotherapy (HDRT, 20-70 Gy) and low-dose radiotherapy (LDRT, 1-10 Gy) for metastatic cancer patients who had undergone immunotherapy. HDRT or HDRT+LDRT was conducted in two respective groups and the treatment group was determined according to the disease status of participants, not randomization. Immunotherapy was maintained in this clinical study. Therefore, we aim to investigate this abscopal effect from adding LDRT to HDRT, irrespective of previous immunotherapy, in this multicenter, single-arm study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SBRT + LDRT | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SBRT + LDRT | Radiation | Stereotactic body radiotherapy (SBRT) and low-dose radiotherapy (LDRT) are administered concurrently. SBRT is administered three times, at intervals of 1-2 days, and patients are treated with LDRT along with SBRT. LDRT is planned to irradiate EQD2 6 Gy considering the scattered dose caused by SBRT. |
| Measure | Description | Time Frame |
|---|---|---|
| Abscopal effect rate of low-dose radiotherapy lesions | The proportion of patients with an abscopal response of low-dose radiotherapy lesions assessed by RECIST v1.1 | 3 months after completion of radiotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Abscopal effect rate of low-dose radiotherapy lesions | The proportion of patients with an abscopal response of low-dose radiotherapy lesions assessed by RECIST v1.1 | 1, 6, and 12 months after completion of radiotherapy |
| Overall response rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jae Sik Kim, MD | Contact | +82-2-709-3254 | icarusky@schmc.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Ah Ram Chang, MD, PhD | Soonchunhayng Universtiy Seoul Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul Metropolitan Government Seoul National University Boramae Medical Center | Recruiting | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41046657 | Derived | Li H, Kwon J, Kim HJ, Kim BH. Immune-modulatory effects of low-dose radiotherapy through macrophage polarization and transcriptional rewiring in triple-negative breast cancer. Biochem Biophys Res Commun. 2025 Oct 30;786:152711. doi: 10.1016/j.bbrc.2025.152711. Epub 2025 Sep 26. |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D016609 | Neoplasms, Second Primary |
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| OTHER |
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|
The proportion of patients showing complete or partial response of metastatic lesions
| 1, 3, 6, and 12 months after completion of radiotherapy |
| Progression-free survival rate | From the date of enrollment to the date of progression or death assessed by RECIST v1.1 | 12 months after completion of radiotherapy |
| Overall survival rate | From the date of enrollment to the date of death or last follow-up assessed by RECIST v1.1 | 12 months after completion of radiotherapy |
| Adverse event | The proportion of patients with treatment-related adverse events as assessed by CTCAE v5.0 | 12 months after completion of radiotherapy |
| Immune cell subsets of peripheral blood and tissue samples | Number of immune cell count | 1 and 3 months after completion of radiotherapy |
| Soonchunhyang University Seoul Hospital | Not yet recruiting | Seoul | South Korea |
|
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |