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| Name | Class |
|---|---|
| Korean Radiation Oncology Group | UNKNOWN |
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This study evaluates hippocampus-sparing whole-brain radiotherapy with simultaneous integrated boost for patients with multiple brain metastases from non-small cell lung cancer. The primary endpoint is intracranial progression free survival, and secondary endpoints are verbal neurocognitive function, overall survival, adverse events according to CTCAE v4.03, and quality of life.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | WBRT with hippocampus-sparing and SIB |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WBRT with hippocampus-sparing and SIB | Radiation | Radiotherapy could be delivered in 5, 8, or 10 fractions according to participating investigator's choice. The prescribed doses are as below; Fractions 5fxs 8fxs 10fxs Whole brain 20 Gy 24 Gy 25 Gy Gross tumor 30 Gy 40 Gy 40 Gy |
| Measure | Description | Time Frame |
|---|---|---|
| Intracranial progression free survival | Time from the date of start of radiotherapy to the date of death or intracranial progression | until 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Verbal neurocognitive function (Seoul Verbal Learning Test-Elderly, SVLT-E) | The relative decline in SVLT-E score from baseline to below time frame; ΔSVLT = (SVLTB - SVLTF) ÷ SVLTB, where B=baseline and F=follow-up. | 3,6,12 months |
| Overall survival |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yong Chan Ahn, MD, PhD | Contact | +82-2-3410-2602 | ycahn.ahn@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 |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Time from the date of start of radiotherapy to the date of death from any cause
| until 12 months |
| Adverse events | CTCAE v4.03 | 3,6,12 months |
| Quality of life | EORTC QLQ-C30 and BN20 | 3,6,12 months |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |