Chemotherapy With or Without Radiosurgery for Asymptomatic Oligo Brain Metastasis
Nonsmall Cell Lung Cancer
Conditions: official terms
Carcinoma, Non-Small-Cell Lung
Conditions: Keywords
Asymptomatic brain metastasis, NSCLC, GKS
Study Type
Study Phase
Phase 3
Study Design
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Name: Radiosurgery Type: Radiation
Name: Observation Type: Radiation
Overall Status
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
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
Samsung Medical Center
Seoul, Korea, Republic of
Status: Recruiting
Contact: Myung-Ju Ahn, Pf - 822-3410-3459 -
Start Date
June 2008
Samsung Medical Center
Samsung Medical Center
Record processing date processed this data on July 28, 2015 page