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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01130766
First received: May 25, 2010
Last updated: NA
Last verified: April 2010
History: No changes posted
  Purpose

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 Intervention Phase
Non-small Cell Lung Cancer
Procedure: stereotactic radiosurgery (SRS)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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)

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • time to CNS progression [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • time to symptomatic brain metastasis [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • quality of life [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • cause of death (neurologic vs. others) [ Time Frame: 36 months ] [ Designated as safety issue: No ]
  • neurocognitive function [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 176
Study Start Date: June 2008
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01130766

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

No publications provided

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
Study First Received: May 25, 2010
Last Updated: May 25, 2010
Health Authority: Korea: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on August 18, 2014