Gefitinib in Treating Patients With Stage IIIA Non-Small Cell Lung Cancer
Recruitment status was: Recruiting
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.
Procedure: neoadjuvant therapy
Procedure: therapeutic conventional surgery
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|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|
- Response rate [ Designated as safety issue: No ]
- Complete resection rate [ Designated as safety issue: No ]
- Overall survival rate [ Designated as safety issue: No ]
- Median disease-free survival [ Designated as safety issue: No ]
- Complete pathological response rate [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
|Study Start Date:||November 2006|
|Estimated Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00616499
|Korea, Republic of|
|Seoul National University Hospital|
|Seoul, Korea, Republic of, 110-744|
|Yonsei Cancer Center at Yonsei University Medical Center|
|Seoul, Korea, Republic of, 120-752|
|Samsung Medical Center|
|Seoul, Korea, Republic of, 135-710|
|Asan Medical Center - University of Ulsan College of Medicine|
|Seoul, Korea, Republic of, 138-736|
|Study Chair:||Joo-Hang Kim, MD||Yonsei University|