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

Study Overview
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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.

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

Conditions
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Non-small Cell Lung Cancer

Intervention / Treatment
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* Procedure: stereotactic radiosurgery (SRS)


Participation Criteria
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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: Well circumscribed tumor(s) with brain edema Grade 0-1 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stereotactic radiosurgery (SRS)<br> | Procedure: stereotactic radiosurgery (SRS)<br>* Stereotactic radiosurgery using γ-rays from radioactive Cobalt-60 installed in Gamma Knife (Elekta Instruments, Stockholm, Sweden)<br>|
| No Intervention: observation<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non-small Cell Lung Cancer, Asymptomatic brain metastasis, Stereotactic radiosurgery (SRS)