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Chemotherapy With or Without Radiosurgery for Asymptomatic Oligo Brain Metastasis
Conditions
Nonsmall Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords
Asymptomatic brain metastasis, NSCLC, GKS
Study Type
Interventional
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Radiosurgery
Type: Radiation
Name: Observation
Type: Radiation
Overall Status
Recruiting
Summary
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.
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
Criteria: Inclusion Criteria:
1. Histologically confirmed non-small cell lung cancer with synchronous brain metastases
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:
1. severe co-morbid illness and/or active infections
2. pregnant or lactating women
3. RTOG neurologic function status of 1~4
4. Uncontrollable extracranial metastases
1. Histologically confirmed non-small cell lung cancer with synchronous brain metastases
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:
1. severe co-morbid illness and/or active infections
2. pregnant or lactating women
3. RTOG neurologic function status of 1~4
4. Uncontrollable extracranial metastases
Location
Samsung Medical Center
Seoul, Korea, Republic of
Status: Recruiting
Contact: Myung-Ju Ahn, Pf - 822-3410-3459 - silkahn@skku.edu
Start Date
June 2008
Sponsors
Samsung Medical Center
Source
Samsung Medical Center
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page