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Efficacy of Gefitinib for Brain Metastasis of Non-Small Cell Lung Cancer

NCT00614809 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2008-02-22

No results posted yet for this study

Summary

This is a non-randomized open-label uncontrolled phase II trial evaluating efficacy and toxicity of gefitinib in patients with asymptomatic advanced NSCLC who was benefitted by first line chemotherapy. Patients with stage IV NSCLC who have one or more asymptomatic brain metastasis who was benefitted by first line chemotherapy will receive oral gefitinib 250mg once daily until disease progression or unacceptable toxicity. These patients' direct DNA sequencing of tumor tissue EGFR exons 18-21 will be analyzed The response was evaluated by RECIST criteria after the patient received gefitinib 6 weeks.If the patients present with progress disease of brain metastasis after the therapy of gefitinib, the patients will receive irradiation of brain metastasis.If the response is stable disease,partial response or complete response,he will be examined by brain MRI every 12 weeks.

Conditions

Interventions

DRUG

gefitinib

gefitinib 250mg qd until disease progression or unacceptable toxicity.

Sponsors & Collaborators

  • Guangdong Provincial People's Hospital

    lead OTHER

Principal Investigators

  • Wu yilong, MD · Director of cancer center of Guangdong PPH

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2010-03-31
Completion
2010-12-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00614809 on ClinicalTrials.gov