Spots Global Cancer Trial Database for Gefitinib in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer
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Trial Identification
Brief Title: Gefitinib in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer
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 ID: NCT00616499
Conditions
Study Description
Brief Summary: 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.
Detailed Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Seoul National University Hospital, Seoul, , Korea, Republic of
Yonsei Cancer Center at Yonsei University Medical Center, Seoul, , Korea, Republic of
Samsung Medical Center, Seoul, , Korea, Republic of
Asan Medical Center - University of Ulsan College of Medicine, Seoul, , Korea, Republic of
Contact Details
Name: Joo-Hang Kim, MD
Affiliation: Yonsei University
Role: STUDY_CHAIR
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