Chemotherapy With or Without Radiosurgery for Asymptomatic Oligo Brain Metastasis

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: NCT01301560
Recruitment Status : Unknown
Verified February 2011 by Samsung Medical Center.
Recruitment status was:  Recruiting
First Posted : February 23, 2011
Last Update Posted : February 23, 2011
Information provided by:
Samsung Medical Center

February 21, 2011
February 23, 2011
February 23, 2011
June 2008
May 2013   (Final data collection date for primary outcome measure)
overall survival [ Time Frame: 1 year after the enrollment of the last patient ]
Same as current
No Changes Posted
Time to CNS progression [ Time Frame: 1 year after the enrollment of the last patient ]
Same as current
Not Provided
Not Provided
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)

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.

Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Nonsmall Cell Lung Cancer
  • Radiation: Radiosurgery
    Gamma knife surgery for asymptomatic oligo-metastasis to brain from NSCLC
  • Radiation: Observation
    No local treatment
  • Experimental: Radiosurgery arm
    Radiosurgery before palliative chemotherapy
    Intervention: Radiation: Radiosurgery
  • No Intervention: Observation arm
    No radiotherapy or local treatment until specific symptoms or sign developed
    Intervention: Radiation: Observation
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):762-8. doi: 10.1093/annonc/mdu584. Epub 2014 Dec 23.

*   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 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Histologically confirmed non-small cell lung cancer with synchronous brain metastases
  2. 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
  3. No prior surgical treatment or RT for brain metastases
  4. No leptomeningeal metastases by MRI or cerebrospinal fluid evaluation
  5. 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:

  1. severe co-morbid illness and/or active infections
  2. pregnant or lactating women
  3. 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
Myung-Ju Ahn / Professor, Samsung Medical Center
Samsung Medical Center
Not Provided
Not Provided
Samsung Medical Center
February 2011

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