Gefitinib in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT00616499|
Recruitment Status : Unknown
Verified September 2008 by National Cancer Institute (NCI).
Recruitment status was: Recruiting
First Posted : February 15, 2008
Last Update Posted : February 9, 2009
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Drug: gefitinib Procedure: neoadjuvant therapy Procedure: therapeutic conventional surgery||Phase 2|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||November 2006|
|Estimated Primary Completion Date :||November 2010|
- Response rate
- Complete resection rate
- Overall survival rate
- Median disease-free survival
- Complete pathological response rate
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00616499
|Korea, Republic of|
|Seoul National University Hospital||Recruiting|
|Seoul, Korea, Republic of, 110-744|
|Contact: Contact Person 82-2-2072-1742|
|Yonsei Cancer Center at Yonsei University Medical Center||Recruiting|
|Seoul, Korea, Republic of, 120-752|
|Contact: Joo-Hang Kim, MD 82-2-2228-8131 email@example.com|
|Samsung Medical Center||Recruiting|
|Seoul, Korea, Republic of, 135-710|
|Contact: Contact Person 82-2-3410-1247|
|Asan Medical Center - University of Ulsan College of Medicine||Recruiting|
|Seoul, Korea, Republic of, 138-736|
|Contact: Contact Person 82-2-3010-7282|
|Study Chair:||Joo-Hang Kim, MD||Yonsei University|