Back to resultsAsymptomatic Brain Metastasis in Non-small Cell Lung Cancer (NSCLC)
Primary Purpose
Non-small Cell Lung Cancer
Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
stereotactic radiosurgery (SRS)
Sponsored by
About this trial
This is an interventional treatment trial for Non-small Cell Lung Cancer focused on measuring Non-small Cell Lung Cancer, Asymptomatic brain metastasis, Stereotactic radiosurgery (SRS)
Eligibility Criteria
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
Sites / Locations
- Samsung Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
stereotactic radiosurgery (SRS)
observation
Arm Description
Outcomes
Primary Outcome Measures
Overall survival
Secondary Outcome Measures
time to CNS progression
time to symptomatic brain metastasis
quality of life
cause of death (neurologic vs. others)
neurocognitive function
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01130766
Brief Title
Asymptomatic Brain Metastasis in Non-small Cell Lung Cancer (NSCLC)
Official Title
Randomized Phase III Trial of Stereotactic Radiosurgery (SRS) Versus Observation for Patients With Asymptomatic Cerebral Oligo-metastases in Non-small Cell Lung Cancer (NSCLC)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2010
Overall Recruitment Status
Unknown status
Study Start Date
June 2008 (undefined)
Primary Completion Date
May 2011 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-small Cell Lung Cancer
Keywords
Non-small Cell Lung Cancer, Asymptomatic brain metastasis, Stereotactic radiosurgery (SRS)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
176 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
stereotactic radiosurgery (SRS)
Arm Type
Experimental
Arm Title
observation
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
stereotactic radiosurgery (SRS)
Intervention Description
Stereotactic radiosurgery using γ-rays from radioactive Cobalt-60 installed in Gamma Knife (Elekta Instruments, Stockholm, Sweden)
Primary Outcome Measure Information:
Title
Overall survival
Time Frame
36 months
Secondary Outcome Measure Information:
Title
time to CNS progression
Time Frame
36 months
Title
time to symptomatic brain metastasis
Time Frame
36 months
Title
quality of life
Time Frame
36 months
Title
cause of death (neurologic vs. others)
Time Frame
36 months
Title
neurocognitive function
Time Frame
36 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myungju Ahn, M.D., Ph.D.
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul,
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Asymptomatic Brain Metastasis in Non-small Cell Lung Cancer (NSCLC)
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