Chemotherapy With or Without Radiosurgery for Asymptomatic Oligo Brain Metastasis

Randomized Phase III Trial of Stereotactic Radiosurgery (SRS) Versus Observation for Patients With Asymptomatic Cerebral Oligo-metastases in Non-small Cell Lung Cancer (NSCLC)

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.

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