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

Phase 3

• Conditions: Non-small Cell Lung Cancer
• Interventions: Procedure: stereotactic radiosurgery (SRS)

• Registration Number: NCT01130766
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Status Verified: 2010-04
• Study First Submitted: 2010-05-25
• Study First Submitted QC: 2010-05-25
• Last Update Submitted: 2010-05-25
• Study First Posted: 2010-05-26
• Last Update Posted: 2010-05-26
• Primary Completion: 2011-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 176

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
stereotactic radiosurgery (SRS)	stereotactic radiosurgery (SRS)	-

Primary Outcome Measures

Name	Time	Method
Overall survival	36 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul,, Korea, Republic of