Chemotherapy With or Without Radiosurgery for Asymptomatic Oligo Brain Metastasis
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 need of radiosurgery is controversial for asymptomatic oligo brain metastasis for non small cell lung cancer (NSCLC). Therefore, the investigators do a randomized study comparing overall survival between two groups with or without radiosurgery for asymptomatic oligo brain metastasis before palliative chemotherapy for NSCLC.
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
February 21, 2011
CompletedFirst Posted
Study publicly available on registry
February 23, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2013
CompletedFebruary 23, 2011
February 1, 2011
4.9 years
February 21, 2011
February 22, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
overall survival
1 year after the enrollment of the last patient
Secondary Outcomes (1)
Time to CNS progression
1 year after the enrollment of the last patient
Study Arms (2)
Radiosurgery arm
EXPERIMENTALRadiosurgery before palliative chemotherapy
Observation arm
NO INTERVENTIONNo radiotherapy or local treatment until specific symptoms or sign developed
Interventions
Gamma knife surgery for asymptomatic oligo-metastasis to brain from NSCLC
Eligibility Criteria
You may qualify if:
- Histologically confirmed non-small cell lung cancer with synchronous brain metastases
- 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 surgical treatment or RT for brain metastases
- No leptomeningeal metastases by MRI or cerebrospinal fluid evaluation
- Patients without any symptoms or signs from brain metastases (RTOG neurologic functions status of 0)
- Age, 18 and over
- ECOG performance status 0-1
- Written informed consent
You may not qualify if:
- severe co-morbid illness and/or active infections
- pregnant or lactating women
- RTOG neurologic function status of 1\~4
- Uncontrollable extracranial metastases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, 135-710, South Korea
Related Publications (1)
Lim SH, Lee JY, Lee MY, Kim HS, Lee J, Sun JM, Ahn JS, Um SW, Kim H, Kim BS, Kim ST, Na DL, Sun JY, Jung SH, Park K, Kwon OJ, Lee JI, Ahn MJ. A randomized phase III trial of stereotactic radiosurgery (SRS) versus observation for patients with asymptomatic cerebral oligo-metastases in non-small-cell lung cancer. Ann Oncol. 2015 Apr;26(4):762-768. doi: 10.1093/annonc/mdu584. Epub 2014 Dec 23.
PMID: 25538174DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
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
February 21, 2011
First Posted
February 23, 2011
Study Start
June 1, 2008
Primary Completion
May 1, 2013
Last Updated
February 23, 2011
Record last verified: 2011-02