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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01130766
Recruitment Status : Unknown
Verified April 2010 by Samsung Medical Center.
Recruitment status was:  Enrolling by invitation
First Posted : May 26, 2010
Last Update Posted : May 26, 2010
Information provided by:
Samsung Medical Center

May 25, 2010
May 26, 2010
May 26, 2010
June 2008
May 2011   (Final data collection date for primary outcome measure)
Overall survival [ Time Frame: 36 months ]
Same as current
No Changes Posted
  • time to CNS progression [ Time Frame: 36 months ]
  • time to symptomatic brain metastasis [ Time Frame: 36 months ]
  • quality of life [ Time Frame: 36 months ]
  • cause of death (neurologic vs. others) [ Time Frame: 36 months ]
  • neurocognitive function [ Time Frame: 36 months ]
Same as current
Not Provided
Not Provided
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)
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.
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Non-small Cell Lung Cancer
Procedure: stereotactic radiosurgery (SRS)
Stereotactic radiosurgery using γ-rays from radioactive Cobalt-60 installed in Gamma Knife (Elekta Instruments, Stockholm, Sweden)
  • Experimental: stereotactic radiosurgery (SRS)
    Intervention: Procedure: stereotactic radiosurgery (SRS)
  • No Intervention: observation
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
Not Provided
May 2011   (Final data collection date for primary outcome measure)

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:

      1. Well circumscribed tumor(s) with brain edema Grade 0-1
      2. 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
Not Provided
Not Provided
Myungju Ahn Ph.D., M.D., Samsung Medical Center
Samsung Medical Center
Not Provided
Principal Investigator: Myungju Ahn, M.D., Ph.D. Samsung Medical Center
Samsung Medical Center
April 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP