NCT01926483Unknown2 期
A Prospective, Phase II Trial of a Trimodality Regimen for Stage III (N2) Non-small-cell Lung Cancer Using Concurrent Chemoradiotherapy as Induction Treatment Followed by Subsequent Resection
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- PFS
研究概览
简要总结
The investigators hypothesized that the Neoadjuvant Chemoradiotherapy was a beneficial treatment for Patients with Stage IIIA-N2 Non-Small Cell Lung Cancer, so we try to evaluate the security of treatment, the QoL of patients and the influence to the PFS and OS.
详细描述
Scheme:
Patients will receive different chemotherapy regimens depending on the pathological type.
Squamous cell carcinoma:Docetaxel/Cisplatin and concurrent radiation (46Gy/23f) followed by surgery, consolidate Docetaxel/Cisplatin 2 cycles.
Non-squamous cell carcinoma:Pemetrexed/Cisplatin and concurrent radiation (46Gy/23f) followed by surgery, consolidate Pemetrexed/Cisplatin 2 cycles.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18≤Age≤65;
- •ECOG performance status of 0 or 1;
- •Pathological diagnosis with Stage IIIA-N2 NSCLC which is clinically resectable and the N2 is diagnosed by either mediastinoscopy,EBUS,PET/CT;
- •WBC≥4.0×109/l, ANC≥1.5×109/l, PLT≥100.0×109/l, Hb≥90g/l;hepatorenal function is normal;
- •Without a history of other malignancies before enrollment, except for non-melanoma skin cancer, in situ cervical cancer;
- •The patient can understand the research and sign the informed consent.
排除标准
- •Female in pregnancy or lactating;Female of childbearing age without contraception;
- •With acute infection or other serious underlying disease;
- •With a significant history of neurological of psychiatric disease，including the dementia which may affect the ability to understand and sign the informed consent;
- •Have received other treatment within the last 30 days before enrollment;
- •With uncontrollable diabetes(blood glucose is unstable after treatment or FBG≥8mol/L).
结局指标
主要结局
PFS
时间窗: up to 3 years
次要结局
- QOL(up to 3 years)
- OS(up to 3 years)
- Adverse events(participants will be followed for the duration of hospital stay,an expected average of 100 days and every 3 months thereafter for 5 years)
研究者
研究点 (1)
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