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The prognosis of NSCLC patients with asymptomatic brain metastasis, who are not treated with SRS or WBRT has not been fully investigated yet. This randomized phase III trial is conducted to determine the exact role of SRS in NSCLC patients with asymptomatic oligo brain metastases whether early treatment with SRS would improve survival even in patients with asymptomatic brain metastasis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| stereotactic radiosurgery (SRS) | Experimental |
| |
| observation | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stereotactic radiosurgery (SRS) | Procedure | Stereotactic radiosurgery using γ-rays from radioactive Cobalt-60 installed in Gamma Knife (Elekta Instruments, Stockholm, Sweden) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival | 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| time to CNS progression | 36 months | |
| time to symptomatic brain metastasis | 36 months | |
| quality of life |
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Inclusion Criteria:
Histologically confirmed non-small cell lung cancer with synchronous brain metastases (diagnosis of brain lesion before or within 2 months from diagnosis of the primary site tumor)
One to 4 intraparenchymal brain metastases by contrast-enhanced MRI, meeting the following criteria:
Well circumscribed tumor(s) with brain edema Grade 0-1
Maximum diameter ≤ 3.0 cm
No prior complete resection of all known brain metastases or RT â‘£ No leptomeningeal metastases by MRI or cerebrospinal fluid evaluation
Exclusion Criteria:
severe co-morbid illness and/or active infections â‘¡ pregnant or lactating women
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| Name | Affiliation | Role |
|---|---|---|
| Myungju Ahn, M.D., Ph.D. | Samsung Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Seoul | South Korea |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| ID | Term |
|---|---|
| D016634 | Radiosurgery |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| 36 months |
| cause of death (neurologic vs. others) | 36 months |
| neurocognitive function | 36 months |
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |