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
  Purpose

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.


Condition Intervention Phase
Nonsmall Cell Lung Cancer
Radiation: Radiosurgery
Radiation: Observation
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety 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: 1 year after the enrollment of the last patient ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to CNS progression [ Time Frame: 1 year after the enrollment of the last patient ] [ Designated as safety issue: No ]

Estimated Enrollment: 176
Study Start Date: June 2008
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Radiosurgery arm
Radiosurgery before palliative chemotherapy
Radiation: Radiosurgery
Gamma knife surgery for asymptomatic oligo-metastasis to brain from NSCLC
No Intervention: Observation arm
No radiotherapy or local treatment until specific symptoms or sign developed
Radiation: Observation
No local treatment

  Eligibility

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

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
  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: NCT01301560

Contacts
Contact: Myung-Ju Ahn, Pf 82-2-3410-3459 silkahn@skku.edu

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Myung-Ju Ahn, Pf    822-3410-3459    silkahn@skku.edu   
Sponsors and Collaborators
Samsung Medical Center
  More Information

No publications provided

Responsible Party: Myung-Ju Ahn / Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01301560     History of Changes
Other Study ID Numbers: 2008-05-024
Study First Received: February 21, 2011
Last Updated: February 22, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by Samsung Medical Center:
Asymptomatic brain metastasis
NSCLC
GKS

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 July 24, 2014