A Prospective Randomized Phase Ⅱ Study of Nimotuzumab Combined With Chemoradiotherapy for Unresectable, Locally Advanced Squamous Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
This Phase II randomized study is to determine the efficacy and toxicity of Nimotuzumab in combined with chemoradiotherapy for unresectable,local advanced squamous cell lung cancer.
详细描述
This Phase II randomized study is to determine the efficacy and toxicity of Nimotuzumab combined with chemoradiotherapy for unresectable,locally advanced squamous cell lung cancer.
All patients were planned to receive radical dose of chest radiation and concurrent chemotherapy of weekly docetaxel and cisplatin, each of 1 day's duration.
Nimotuzumab group was treated with weekly nimotuzumab (200mg, IV) combined with chemoradiotherapy, while control group was treated with chemoradiotherapy.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •histologically confirmed squamous cell lung cancer
- •patients have measurable or evaluable lesions based on the Response Evaluation Criteria in Solid Tumors (RECIST) criteria
- •unresectable phase IIIA(N2) and IIIB lung cancer confirmed by CT or MRI
- •ECOG performance status 0-1
- •Previously treated with chemotherapy or treatment-naive
- •no previous chest radiotherapy, immunotherapy or biotherapy.
- •hemoglobin≥10 mg/dL, platelet≥100000/μL,absolute neutrophil count ≥1500/μL
- •serum creatinine ≤1.25 times the upper normal limit(UNL), or creatinine clearance≥60 ml/min
- •bilirubin ≤1.5 times UNL, AST（SGOT）≤2.5 times UNL ,ALT（SGPT）≤2.5 times UNL,alkaline phosphatase ≤5 times UNL
- •FEV1 >0.8 L
- •CB6 within normal limits
- •patients and their family signed the informed consents
排除标准
- •adenosquamous carcinoma
- •previous or recent another malignancy, except for nonmelanoma skin cancer or cervical cancer in situ
- •contraindication for chemotherapy
- •women in pregnancy, lactation period, or no pregnancy test 14 days before the first dose
- •women who has the probability of pregnancy without contraception
- •tendency of hemorrhage
- •in other clinical trials within 30 days
- •addicted in drugs or alcohol, AIDS patients
- •uncontrollable seizure or psychotic patients without self-control ability
- •severe allergy or idiosyncrasy
- •not suitable for this study judged by researchers
研究组 & 干预措施
Nimotuzumab
Daily RT to the chest, concurrent chemotherapy of weekly docetaxel and cisplatin, and concurrent weekly Nimotuzumab.
干预措施: Nimotuzumab (Drug)
Nimotuzumab
Daily RT to the chest, concurrent chemotherapy of weekly docetaxel and cisplatin, and concurrent weekly Nimotuzumab.
干预措施: docetaxel and cisplatin (Drug)
Nimotuzumab
Daily RT to the chest, concurrent chemotherapy of weekly docetaxel and cisplatin, and concurrent weekly Nimotuzumab.
干预措施: daily RT to the chest (Radiation)
Control
Daily RT to the chest, concurrent chemotherapy of weekly docetaxel and cisplatin.
干预措施: docetaxel and cisplatin (Drug)
Control
Daily RT to the chest, concurrent chemotherapy of weekly docetaxel and cisplatin.
干预措施: daily RT to the chest (Radiation)
结局指标
主要结局
overall survival
时间窗: 3 years
次要结局
- progression-free survival(3 years)
- rate of grade 3-4 radiation esophagitis(1 years)
- Objective Response Rate(3 years)
- Failure patterns(3 years)
- rate of grade 3-4 radiation pneumonitis(1 year)
研究者
Hui Liu
Professor
Sun Yat-sen University