Radiation Therapy to the Brain or Observation in Preventing Brain Metastases in Patients With Advanced Non-Small Cell Lung Cancer

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: NCT00955695
Recruitment Status : Unknown
Verified January 2010 by National Cancer Institute (NCI).
Recruitment status was:  Not yet recruiting
First Posted : August 10, 2009
Last Update Posted : August 2, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Radiation therapy to the brain may be effective in preventing brain metastases in patients with advanced non-small cell lung cancer. It is not yet known whether radiation therapy is more effective than observation in patients with advanced non-small cell lung cancer.

PURPOSE: This randomized phase III trial is studying radiation therapy to the brain to see how well it works compared with observation in preventing brain metastases in patients with advanced non-small cell lung cancer.

Condition or disease Intervention/treatment Phase
Lung Cancer Drug: erlotinib hydrochloride Drug: gefitinib Other: questionnaire administration Procedure: quality-of-life assessment Radiation: whole-brain radiation therapy Phase 3

Detailed Description:



  • Determine the effectiveness of prophylactic cranial radiotherapy in patients with advanced non-small cell lung cancer that is responsive to gefitinib or erlotinib hydrochloride.


  • Determine the progression-free survival in patients treated with this regimen.
  • Determine the overall survival in patients treated with this regimen.
  • Determine the safety and tolerability of this regimen in these patients.
  • Determine the psycho-neurological effects of this regimen in these patients.
  • Determine the quality of life of patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy regimens (first line vs second line), and disease response status (complete response or partial response vs stable disease). Patients are randomized to 1 of 2 treatment groups.

  • Group 1: Patients undergo prophylactic brain radiotherapy.
  • Group 2: Patients undergo observation. Patients complete quality of life (HVLT, K-ADL, EORTC QLQ-C30, and EORTC-BN20) questionnaires periodically.

After completion of study therapy, patients are followed up periodically.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 242 participants
Allocation: Randomized
Primary Purpose: Prevention
Official Title: A Randomized, Phase III Trial of Prophylactic Cranial Irradiation (PCI) in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) Who Are Nonprogressive on Gefitinib or Erlotinib
Study Start Date : May 2009

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Time to symptomatic brain metastases

Secondary Outcome Measures :
  1. Progression-free survival
  2. Overall survival
  3. Safety and tolerability of prophylactic cranial radiotherapy
  4. Psycho-neurological effects of prophylactic cranial radiotherapy
  5. Quality of life as measured by HVLT, K-ADL, EORTC QLQ-C30, and EORTC-BN20 questionnaires periodically

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


  • Histologically confirmed non-small cell lung cancer

    • Stage IIIB or IV disease
    • Must have had ≥ 8 weeks of gefitinib or erlotinib hydrochloride therapy
  • At least 12 weeks of complete response or partial response since starting gefitinib or erlotinib hydrochloride

    • Stable disease allowed provided 1 of the following criteria is met:

      • EGFR mutation (exon 19 or 21)
      • Having ≥ 2 of the following 3 factors:

        • Female
        • Never smoked
        • Histologically confirmed adenocarcinoma of the lung
  • No evidence of brain metastases by CT scan or MRI within the past 4 weeks


  • ECOG performance status 0-2
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 150,000/mm^3
  • Bilirubin < 1.5 mg/dL
  • Serum creatinine < 1.5 times upper limit of normal


  • See Disease Characteristics
  • Received 1 or 2 prior systemic chemotherapy regimens

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 identifier (NCT number): NCT00955695

Sponsors and Collaborators
National Cancer Center, Korea
Principal Investigator: Chang Geol Lee, MD Yonsei University Identifier: NCT00955695     History of Changes
Other Study ID Numbers: KROG-4-2008-0276
CDR0000639096 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: August 10, 2009    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: January 2010

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the lung
adenosquamous cell lung cancer
bronchoalveolar cell lung cancer
large cell lung cancer
squamous cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action