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

NCT00955695 | Unknown Phase 3

• 2 other identifiers: KROG-4-2008-0276CDR0000639096
• Study Type: interventional
• Target: 242
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Lung Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Time to symptomatic brain metastases

Secondary Outcomes (5)

• 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

Interventions

erlotinib hydrochloride DRUG

gefitinib DRUG

questionnaire administration OTHER

quality-of-life assessment PROCEDURE

whole-brain radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Cancer Center, Korea: lead

MeSH Terms

Conditions

Lung Neoplasms; Adenocarcinoma of Lung; Adenocarcinoma, Bronchiolo-Alveolar; Carcinoma, Non-Small-Cell Lung

Interventions

Erlotinib Hydrochloride; Gefitinib

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Chang Geol Lee, MD

  Yonsei University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Purpose: PREVENTION
• Sponsor Type: OTHER GOV

Study Record Dates

• First Submitted: August 7, 2009
• First Posted: August 10, 2009
• Study Start: May 1, 2009
• Last Updated: August 2, 2013

Record last verified: 2010-01