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The need of radiosurgery is controversial for asymptomatic oligo brain metastasis for non small cell lung cancer (NSCLC).
Therefore, the investigators do a randomized study comparing overall survival between two groups with or without radiosurgery for asymptomatic oligo brain metastasis before palliative chemotherapy for NSCLC.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiosurgery arm | Experimental | Radiosurgery before palliative chemotherapy |
|
| Observation arm | No Intervention | No radiotherapy or local treatment until specific symptoms or sign developed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiosurgery | Radiation | Gamma knife surgery for asymptomatic oligo-metastasis to brain from NSCLC |
|
| Measure | Description | Time Frame |
|---|---|---|
| overall survival | 1 year after the enrollment of the last patient |
| Measure | Description | Time Frame |
|---|---|---|
| Time to CNS progression | 1 year after the enrollment of the last patient |
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Inclusion Criteria:
Histologically confirmed non-small cell lung cancer with synchronous brain metastases
One to 4 intraparenchymal brain metastases by contrast-enhanced MRI, meeting the following criteria:
No prior surgical treatment or RT for brain metastases
No leptomeningeal metastases by MRI or cerebrospinal fluid evaluation
Patients without any symptoms or signs from brain metastases (RTOG neurologic functions status of 0)
Age, 18 and over
ECOG performance status 0-1
Written informed consent
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Myung-Ju Ahn, Pf | Contact | 82-2-3410-3459 | silkahn@skku.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | 135-710 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25538174 | Derived | Lim SH, Lee JY, Lee MY, Kim HS, Lee J, Sun JM, Ahn JS, Um SW, Kim H, Kim BS, Kim ST, Na DL, Sun JY, Jung SH, Park K, Kwon OJ, Lee JI, Ahn MJ. A randomized phase III trial of stereotactic radiosurgery (SRS) versus observation for patients with asymptomatic cerebral oligo-metastases in non-small-cell lung cancer. Ann Oncol. 2015 Apr;26(4):762-768. doi: 10.1093/annonc/mdu584. Epub 2014 Dec 23. |
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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 |
| D019370 | Observation |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
| D013238 | Stereotaxic Techniques |
| D019635 | Neurosurgical Procedures |
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| Observation | Radiation | No local treatment |
|
| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013514 |
| Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
| D008722 | Methods |