Oral Navelbine Carboplatin Versus Gefitinib Neoadjuvant Therapy for Resectable EGFR Mutation Positive Stage Ⅱ-ⅢA NSCLC, Prospective, Randomized, Multicenter, Phase Ⅲ Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 590
- 试验地点
- 5
- 主要终点
- 2-year disease free survival
研究概览
简要总结
The purpose of this study is to evaluate the efficiency and safety of Gefitinib Neoadjuvant Therapy and Oral Navelbine Carboplatin Neoadjuvant Therapy for Resectable Stage Ⅱ-ⅢA NSCLC patients with EGFR mutation.
详细描述
Lung cancer is the most common cause of cancer mortality in men and women in the world. LACE meta analysis shows that the 5-year survival rate of post-operation chemotherapy group rose by 5.4%, therefore, adjuvant chemotherapy has been the main treatment after surgery according to National Comprehensive Cancer Network (NCCN) Guideline. But patients have poor compliance due to physical condition after surgery. Compared with adjuvant chemotherapy, neoadjuvant therapy has better patient compliance and tolerance.Targeted therapy, with milder side effect compared with chemotherapy, may be a promising choice to treat NSCLC previously. But to date, there is no enough evidence to support the efficacy and safety of neoadjuvant targeted therapy in patients with EGFR mutation.The purpose of this study is to evaluate the efficiency and safety of Gefitinib Neoadjuvant Therapy vs Oral Navelbine Carboplatin Neoadjuvant Therapy for Resectable NSCLC patients harboring EGFR mutation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologic diagnosis of non small cell lung cancer, Stage Ⅱ-ⅢA before treatment
- •EGFR Gene mutated
- •liver, kidney and bone marrow are functional healthy，WBC>4.0×109/L，PLT>100×109/L Hb>10g/dL;Cr<1.8mg/dL，bilirubin<1.5mg/dL，GPT<1.5 upper limit of normal
- •No vital systems dysfunction or malnutrition
- •No other malignant diseases in 5 years（except non melanoma or Cervical carcinoma in situ）
- •Have never accepted radiation therapy、overall chemotherapy or biotherapy
- •Know the whole protocol，Voluntary participate and sign a consent form
排除标准
- •Tumor has violated the surrounding tissue organs（T4）
- •Preoperative have evidence of distant metastasis including the contralateral mediastinal lymph nodes
- •Arrhythmia need anti-arrhythmic treatment（except for β-blockers or digoxin），Symptomatic coronary artery disease and myocardial ischemia (myocardial infarction) in the past 6 months or more than NYHA class II congestive heart failure
- •Adverse drug control severe hypertension
- •Moderate to severe proteinuria
- •History of HIV infection or activity of chronic hepatitis b or hepatitis c, or other active clinical severe infection
- •Cachexy,organ function decompensation
- •History of chest radiotherapy
- •Not fully control the eye inflammation
- •Epilepsy patients needed treatment（such as Steroids or antiepileptic cure）
- •Interstitial pneumonia
- •Drug abuse and medical, psychological or social conditions may interfere with the patients involved in the research or have an impact on the results of evaluation
- •Known or suspected to study drug allergy or to give any drug allergies associated with this test
- •Any unstable situation or may endanger the patient safety and compliance
- •Fertility and pregnancy or lactation women, and have not been sufficient precautions
研究组 & 干预措施
Oral Navelbine + Carboplatin
Neoadjuvant therapy Patients with EGFR mutation will be recruited and treated with Navelbine + Carboplatin.
干预措施: Oral Navelbine + Carboplatin (Drug)
Gefitinib
Neoadjuvant therapy Patients with EGFR mutation will be recruited and treated with gefitinib.
干预措施: Gefitinib (Drug)
结局指标
主要结局
2-year disease free survival
时间窗: 2 years
次要结局
- Tumor reduction rate(Within 1 month after surgery)
- Postoperative complications(Within 1 month after discharge)
- R0 resection rate(Within 1 month after surgery)
- Postoperative mortality rate(Within 1 month after discharge)
- Pathologic complete response(Within 1 month after surgery)
- Side effects(1 week before surgery)
- Objective response rate(1 week before surgery)
- Standard uptake value(1 week before surgery)
- 5-year overall survival(5 years after surgery)
- Mediastinal lymph nodes clearance(Within 1 month after surgery)
研究者
Guowei Ma
Professor,Chief Physician
Sun Yat-sen University