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)
1 other identifier
interventional
176
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 nonsmall-cell-lung-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
May 25, 2010
CompletedFirst Posted
Study publicly available on registry
May 26, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2011
CompletedMay 26, 2010
April 1, 2010
2.9 years
May 25, 2010
May 25, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall survival
36 months
Secondary Outcomes (5)
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
Study Arms (2)
stereotactic radiosurgery (SRS)
EXPERIMENTALobservation
NO INTERVENTIONInterventions
Stereotactic radiosurgery using γ-rays from radioactive Cobalt-60 installed in Gamma Knife (Elekta Instruments, Stockholm, Sweden)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- severe co-morbid illness and/or active infections ② pregnant or lactating women
- RTOG neurologic function status of 1\~4 ④ Uncontrollable extracranial metastases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Myungju Ahn, M.D., Ph.D.
Samsung Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 25, 2010
First Posted
May 26, 2010
Study Start
June 1, 2008
Primary Completion
May 1, 2011
Last Updated
May 26, 2010
Record last verified: 2010-04