A Randomized Phase II Study Preoperative Chemotherapy Versus Preoperative Concurrent Chemoradiotherapy for Patients With Locally Advanced Non-Small Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To estimate the time to recurrence
研究概览
简要总结
This phase II trial is to compare neoadjuvant chemotherapy with concurrent chemoradiotherapy in patients with locally advanced non-small cell lung cancer (NSCLC) to address optimal induction strategy.
详细描述
Management of locally advanced non-small cell lung cancer (NSCLC) remains a challenge. Both local relapses and distant metastases are frequent, with 5-year survival of 3-17% for inoperable disease. Staging has historically subdivided stage III disease into clinical stage IIIA, thought to be potentially amenable to surgery, and stage IIIB, treated by defi nitive radiotherapy or radiochemotherapy. This phase II trial is to compare neoadjuvant chemotherapy with concurrent chemoradiotherapy in patients with locally advanced NSCLC to address optimal induction strategy.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histopathologic diagnosis of non small-cell lung cancer
- •Clinical stage IIIA and/or IIIB without pleural effusion
- •ECOG functional status 0 or 1
- •No renal function alteration (GFR >50%)
- •No hepatic function alteration (ALT and AST less than 2 times its normal value)
- •Leucocytes more than 2,000/mcl
- •Hemoglobin more than 10mg/dL
- •Platelets more than 100,000/mcl
排除标准
- •Active uncontrolled infection.
- •Serious concomitant disorders that would compromise the safety of patient or compromise the patient's ability to tolerate therapy.
- •MI within preceding 6 months or symptomatic heart disease including unstable angina, congestive heart failure, or uncontrolled arrhythmia.
- •Significant neurological or mental disorder.
- •Second primary malignancy.
- •Pregnant or nursing.
研究组 & 干预措施
Pre-operative chemotherapy
Docetaxel 75 mg/m2 + Carboplatin AUC(area under the curve)=6 on D1, q3 weeks, Pre-Op & Post-Op (total 4 cycles)
干预措施: Pre-operative chemotherapy (Drug)
Pre-operative concurrent chemoradiation therapy
干预措施: Pre-operative concurrent chemoradiation therapy (Other)
结局指标
主要结局
To estimate the time to recurrence
时间窗: Every 3 months
次要结局
- To assess the pathologic complete response rate and the complete resection rate(Every 4 weeks)
- To estimate toxicities(Every 4 weeks)