Chemotherapy With or Without Radiosurgery for Asymptomatic Oligo Brain Metastasis
NCT ID: NCT01301560
Last Updated: 2011-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
176 participants
INTERVENTIONAL
2008-06-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Radiosurgery arm
Radiosurgery before palliative chemotherapy
Radiosurgery
Gamma knife surgery for asymptomatic oligo-metastasis to brain from NSCLC
Observation arm
No radiotherapy or local treatment until specific symptoms or sign developed
Observation
No local treatment
Interventions
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Radiosurgery
Gamma knife surgery for asymptomatic oligo-metastasis to brain from NSCLC
Observation
No local treatment
Eligibility Criteria
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Inclusion Criteria
2. 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
3. No prior surgical treatment or RT for brain metastases
4. No leptomeningeal metastases by MRI or cerebrospinal fluid evaluation
5. Patients without any symptoms or signs from brain metastases (RTOG neurologic functions status of 0)
6. Age, 18 and over
7. ECOG performance status 0-1
8. Written informed consent
Exclusion Criteria
2. pregnant or lactating women
3. RTOG neurologic function status of 1\~4
4. Uncontrollable extracranial metastases
18 Years
ALL
No
Sponsors
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Samsung Medical Center
OTHER
Responsible Party
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Samsung Medical Center
Locations
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Samsung Medical Center
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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2008-05-024
Identifier Type: -
Identifier Source: org_study_id
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