Chemotherapy With or Without Radiosurgery for Asymptomatic Oligo Brain Metastasis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Samsung Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01301560
First received: February 21, 2011
Last updated: February 22, 2011
Last verified: February 2011

February 21, 2011
February 22, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01301560 on ClinicalTrials.gov Archive Site
Time to CNS progression [ Time Frame: 1 year after the enrollment of the last patient ] [ Designated as safety issue: No ]
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
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
176
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
Both
18 Years and older
No
Contact: Myung-Ju Ahn, Pf 82-2-3410-3459 silkahn@skku.edu
Korea, Republic of
 
NCT01301560
2008-05-024
No
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