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Trial Title:
Chemotherapy With or Without Radiosurgery for Asymptomatic Oligo Brain Metastasis
NCT ID:
NCT01301560
Condition:
Nonsmall Cell Lung Cancer
Conditions: Official terms:
Lung Neoplasms
Neoplasm Metastasis
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords:
Asymptomatic brain metastasis
NSCLC
GKS
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Unknown status
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Radiation
Intervention name:
Radiosurgery
Description:
Gamma knife surgery for asymptomatic oligo-metastasis to brain from NSCLC
Arm group label:
Radiosurgery arm
Intervention type:
Radiation
Intervention name:
Observation
Description:
No local treatment
Arm group label:
Observation arm
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Samsung Medical Center
Address:
City:
Seoul
Zip:
135-710
Country:
Korea, Republic of
Status:
Recruiting
Contact:
Last name:
Myung-Ju Ahn, Pf
Phone:
822-3410-3459
Email:
silkahn@skku.edu
Start date:
June 2008
Lead sponsor:
Agency:
Samsung Medical Center
Agency class:
Other
Source:
Samsung Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT01301560
