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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

176 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Non-small Cell Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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stereotactic radiosurgery (SRS)

Group Type EXPERIMENTAL

stereotactic radiosurgery (SRS)

Intervention Type PROCEDURE

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

observation

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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stereotactic radiosurgery (SRS)

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No