A Phase II Trial of Neoadjuvant Erlotinib (Tarceva®) Followed by Surgery for Selected Patients With Stage IIIA, N2-positive Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Pathologic down-staging
研究概览
简要总结
This study propose neoadjuvant chemotherapeutic role by erlotinib.
详细描述
It is widely accepted that patients with locally advanced non-small cell lung cancer would have better outcome with neoadjuvant therapy followed by surgery than surgery alone. However what should be the standard treatment option is still unclear.
Erlotinib (Tarceva®)is an oral inhibitor of epidermal growth factor receptor (EGFR) tyrosine kinase and its anti-neoplastic effect is approved especially women, patients with adenocarcinoma, non-smoker and Asian population. Moreover if the malignant tissue has EGFR mutation, its efficacy is known to be enhanced.
So we expect that in those population, patients with locally advanced, N2 positive, erlotinib would be more beneficial than conventional cytotoxic chemotherapy in safety and convenience as neoadjuvant therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Pathologically confirmed N2 positive and stage IIIA non-small cell lung cancer
- •Has more than 2 conditions out of following 3 conditions ; adenocarcinoma, non-smoker, women
- •Age ≥ 18 years and ECOG performance 0~1
- •Has measurable lesion by RECIST 1.1
- •No previous chemotherapy or radiation therapy
- •Adequate organ function by following; ANC ≥1,500/uL, hemoglobin ≥9.0g/dL, platelet ≥100,000/uL, PaO2 ≥ 60 mmHg, Serum Cr < 1 x UNL or creatinine clearance > 60 ml/min, Serum bilirubin < 1 x UNL, AST (SGOT) and ALT (SGPT) < 2.5 x UNL, alkaline phosphatase < 5 x UNL
- •Written informed consent form
排除标准
- •Pulmonary carcinoid tumor
- •Previous chemotherapy or radiation therapy
- •Previous history of malignancy within 5 years from study entry except treated non-melanomatous skin cancer or uterine cervical cancer in situ
- •Known allergic history of erlotinib
- •Interstitial lung disease or fibrosis on chest radiogram
- •Active infection, uncontrolled systemic disease (cardiopulmonary insufficiency, fatal arrhythmias, hepatitis)
- •Pregnant or nursing women
结局指标
主要结局
Pathologic down-staging
时间窗: 36 months
次要结局
- Response rate(36 months)
- Toxicity(36 months)
- Progression free survival(36 months)
- Overall survival(36 months)
研究者
Keunchil Park
Principal investigator
Samsung Medical Center