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

August 1, 2013 updated by: National Cancer Center, Korea

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

242

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time to symptomatic brain metastases

Secondary Outcome Measures

Outcome Measure
Progression-free survival
Overall survival
Safety and tolerability of prophylactic cranial radiotherapy
Psycho-neurological effects of prophylactic cranial radiotherapy
Quality of life as measured by HVLT, K-ADL, EORTC QLQ-C30, and EORTC-BN20 questionnaires periodically

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Center, Korea

Investigators

  • Principal Investigator: Chang Geol Lee, MD, Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2009

Study Registration Dates

First Submitted

August 7, 2009

First Submitted That Met QC Criteria

August 7, 2009

First Posted (Estimate)

August 10, 2009

Study Record Updates

Last Update Posted (Estimate)

August 2, 2013

Last Update Submitted That Met QC Criteria

August 1, 2013

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KROG-4-2008-0276
  • CDR0000639096 (Registry Identifier: PDQ (Physician Data Query))

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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