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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by National Cancer Institute (NCI).
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00955695
First received: August 7, 2009
Last updated: August 1, 2013
Last verified: January 2010
  Purpose

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

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Time to symptomatic brain metastases [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Designated as safety issue: No ]
  • Overall survival [ Designated as safety issue: No ]
  • Safety and tolerability of prophylactic cranial radiotherapy [ Designated as safety issue: Yes ]
  • Psycho-neurological effects of prophylactic cranial radiotherapy [ Designated as safety issue: Yes ]
  • Quality of life as measured by HVLT, K-ADL, EORTC QLQ-C30, and EORTC-BN20 questionnaires periodically [ Designated as safety issue: No ]

Estimated Enrollment: 242
Study Start Date: May 2009
Detailed Description:

OBJECTIVES:

Primary

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

Secondary

  • 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.

  Eligibility

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

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Received 1 or 2 prior systemic chemotherapy regimens
  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: NCT00955695

Sponsors and Collaborators
Korean Radiation Oncology Group at National Cancer Center
Investigators
Principal Investigator: Chang Geol Lee, MD Yonsei University
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00955695     History of Changes
Other Study ID Numbers: KROG-4-2008-0276, CDR0000639096
Study First Received: August 7, 2009
Last Updated: August 1, 2013
Health Authority: Unspecified

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:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Bronchial Neoplasms
Carcinoma, Bronchogenic
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Erlotinib
Gefitinib
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014