Lung Cancer Clinical Trial
Official title:
A Phase II Trial of Neoadjuvant Gefitinib Therapy Based on Mutation Study in Biopsy- Proven Stage IIIA N2 Non-Squamous Non-Small Cell Lung Cancer
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes
needed for cell growth. Giving Gefitinib before surgery may make the tumor smaller and
reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with
stage IIIA non-small cell lung cancer.
OBJECTIVES:
Primary
- To assess the response rate to gefitinib treatment as preoperative induction therapy in
patients with biopsy-proven stage IIIA (pN2) non-squamous non-small cell lung cancer
accompanied by epidermal growth factor receptor (EGFR) mutations.
Secondary
- To determine the complete resection rate in patients treated with this drug.
- To determine the overall survival rate in patients treated with this drug.
- To determine the disease-free survival rate in patients treated with this drug.
- To determine the pathologic complete response rate in patients treated with this drug.
- To determine the toxicity of this drug in these patients.
OUTLINE: This is a multicenter study.
Patients receive oral gefitinib once a day on days 1-28. Treatment repeats every 28 days for
up to 2 courses in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients with resectable disease may undergo surgery.
Patients with unresectable disease may undergo surgery, chemotherapy, and/or radiotherapy.
After completion of study therapy, patients are followed for 2 years.
;
Masking: Open Label, Primary Purpose: Treatment
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