Back to resultsChemotherapy With or Without Radiosurgery for Asymptomatic Oligo Brain Metastasis
Primary Purpose
Nonsmall Cell Lung Cancer
Status
Unknown status
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Radiosurgery
Observation
Sponsored by
About this trial
This is an interventional treatment trial for Nonsmall Cell Lung Cancer focused on measuring Asymptomatic brain metastasis, NSCLC, GKS
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- severe co-morbid illness and/or active infections
- pregnant or lactating women
- RTOG neurologic function status of 1~4
- Uncontrollable extracranial metastases
Sites / Locations
- Samsung Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Radiosurgery arm
Observation arm
Arm Description
Radiosurgery before palliative chemotherapy
No radiotherapy or local treatment until specific symptoms or sign developed
Outcomes
Primary Outcome Measures
overall survival
Secondary Outcome Measures
Time to CNS progression
Full Information
NCT ID
NCT01301560
First Posted
February 21, 2011
Last Updated
February 22, 2011
Sponsor
Samsung Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT01301560
Brief Title
Chemotherapy With or Without Radiosurgery for Asymptomatic Oligo Brain Metastasis
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
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2008 (undefined)
Primary Completion Date
May 2013 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Samsung Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonsmall Cell Lung Cancer
Keywords
Asymptomatic brain metastasis, NSCLC, GKS
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
Radiosurgery arm
Arm Type
Experimental
Arm Description
Radiosurgery before palliative chemotherapy
Arm Title
Observation arm
Arm Type
No Intervention
Arm Description
No radiotherapy or local treatment until specific symptoms or sign developed
Intervention Type
Radiation
Intervention Name(s)
Radiosurgery
Intervention Description
Gamma knife surgery for asymptomatic oligo-metastasis to brain from NSCLC
Intervention Type
Radiation
Intervention Name(s)
Observation
Intervention Description
No local treatment
Primary Outcome Measure Information:
Title
overall survival
Time Frame
1 year after the enrollment of the last patient
Secondary Outcome Measure Information:
Title
Time to CNS progression
Time Frame
1 year after the enrollment of the last patient
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
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
Exclusion Criteria:
severe co-morbid illness and/or active infections
pregnant or lactating women
RTOG neurologic function status of 1~4
Uncontrollable extracranial metastases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Myung-Ju Ahn, Pf
Phone
82-2-3410-3459
Email
silkahn@skku.edu
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Myung-Ju Ahn, Pf
Phone
822-3410-3459
Email
silkahn@skku.edu
12. IPD Sharing Statement
Citations:
PubMed Identifier
25538174
Citation
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.
Results Reference
derived
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Chemotherapy With or Without Radiosurgery for Asymptomatic Oligo Brain Metastasis
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