Asymptomatic Brain Metastasis in Non-small Cell Lung Cancer (NSCLC)

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01130766

Enrollment

176

Registered

2010-05-26

Start date

2008-06-30

Completion date

Unknown

Last updated

2010-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small Cell Lung Cancer

Keywords

Non-small Cell Lung Cancer, Asymptomatic brain metastasis, Stereotactic radiosurgery (SRS)

Brief summary

The prognosis of NSCLC patients with asymptomatic brain metastasis, who are not treated with SRS or WBRT has not been fully investigated yet. This randomized phase III trial is conducted to determine the exact role of SRS in NSCLC patients with asymptomatic oligo brain metastases whether early treatment with SRS would improve survival even in patients with asymptomatic brain metastasis.

Interventions

PROCEDUREstereotactic radiosurgery (SRS)

Stereotactic radiosurgery using γ-rays from radioactive Cobalt-60 installed in Gamma Knife (Elekta Instruments, Stockholm, Sweden)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Histologically confirmed non-small cell lung cancer with synchronous brain metastases (diagnosis of brain lesion before or within 2 months from diagnosis of the primary site tumor) * One to 4 intraparenchymal brain metastases by contrast-enhanced MRI, meeting the following criteria: 1. Well circumscribed tumor(s) with brain edema Grade 0-1 2. Maximum diameter ≤ 3.0 cm * No prior complete resection of all known brain metastases or RT ④ No leptomeningeal metastases by MRI or cerebrospinal fluid evaluation * 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

* severe co-morbid illness and/or active infections ② pregnant or lactating women * RTOG neurologic function status of 1\ 4 ④ Uncontrollable extracranial metastases

Design outcomes

Primary

Measure	Time frame
Overall survival	36 months

Secondary

Measure	Time frame
time to CNS progression	36 months
time to symptomatic brain metastasis	36 months
quality of life	36 months
cause of death (neurologic vs. others)	36 months
neurocognitive function	36 months

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026