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

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ClinicalTrials.gov 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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Non-small Cell Lung Cancer Procedure: stereotactic radiosurgery (SRS) Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2008
Estimated Primary Completion Date : May 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Experimental: stereotactic radiosurgery (SRS) Procedure: stereotactic radiosurgery (SRS)
Stereotactic radiosurgery using γ-rays from radioactive Cobalt-60 installed in Gamma Knife (Elekta Instruments, Stockholm, Sweden)
No Intervention: observation

Primary Outcome Measures :
  1. Overall survival [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. time to CNS progression [ Time Frame: 36 months ]
  2. time to symptomatic brain metastasis [ Time Frame: 36 months ]
  3. quality of life [ Time Frame: 36 months ]
  4. cause of death (neurologic vs. others) [ Time Frame: 36 months ]
  5. neurocognitive function [ Time Frame: 36 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01130766

Korea, Republic of
Samsung Medical Center
Seoul,, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Principal Investigator: Myungju Ahn, M.D., Ph.D. Samsung Medical Center

Responsible Party: Myungju Ahn Ph.D., M.D., Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01130766     History of Changes
Other Study ID Numbers: 2009-01-059
First Posted: May 26, 2010    Key Record Dates
Last Update Posted: May 26, 2010
Last Verified: April 2010

Keywords provided by Samsung Medical Center:
Non-small Cell Lung Cancer
Asymptomatic brain metastasis
Stereotactic radiosurgery (SRS)

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Neoplasm Metastasis
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Neoplastic Processes
Pathologic Processes