NCT00616499Unknown2 期
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
适应症
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 35
- 试验地点
- 4
- 主要终点
- Response rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DISEASE CHARACTERISTICS:
- •Biopsy-proven stage IIIA nonsquamous non-small cell lung cancer
- •pN2 disease proven by mediastinoscopy
- •Meets any of the following criteria:
- •Never smoked
- •EGFR mutations (in exon 18, 19, or 21)*
- •FISH positive for EGFR* NOTE: *Irrespective of smoking history
- •Presence of at least 1 unidimensionally measurable lesion on thoracic CT scan, according to RECIST
- •Feasible to undergo pneumonectomy or lobectomy
- •PATIENT CHARACTERISTICS:
- •Inclusion criteria:
- •ECOG performance status 0-1
- •FEV_1 ≥ 2.0 L in preoperative pulmonary function test
- •Hemoglobin ≥ 9.0 g/dL
- •WBC 4,000-12,000/μL
- •ANC ≥ 1,500/μL
- •Platelet count ≥ 100,000/mm³
- •Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
- •Alkaline phosphatase ≤ 3.0 times ULN
- •AST and ALT ≤ 3.0 times ULN
- •Creatinine ≤ 1.5 times ULN
- •Negative pregnancy test
排除标准
- •Severe complications or infections
- •Pregnant or breast-feeding women
- •Clinically significant heart disease
- •Uncontrolled hepatitis, chronic liver disease, or diabetes mellitus
- •Another active cancer except properly treated carcinoma in situ of the cervix or basal/squamous cell skin carcinoma
- •PRIOR CONCURRENT THERAPY:
- •No prior radiotherapy, chemotherapy, hormone therapy, or target therapy
- •No other concurrent systemic anticancer therapies, including experimental drugs, chemotherapy, immunotherapy, or radiotherapy
结局指标
主要结局
Response rate
次要结局
- Complete resection rate
- Overall survival rate
- Median disease-free survival
- Complete pathological response rate
- Toxicity
研究者
研究点 (4)
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