Phase I/II Clinical Trial of Recombinant Human Endostatin in Combination With Concurrent Chemo-Radiotherapy in the Patients With Unresectable Stage III Non-small-Cell Lung Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Response Rate (RR)
研究概览
简要总结
To evaluate the efficacy and safety of Endostar combined with concurrent chemo-radiotherapy (CCRT) in patients with unresectable stage III non-small-cell lung cancer (NSCLC).
详细描述
OBJECTIVES:
Primary:To assess the treatment response rate (RR) of Endostar in combination with CCRT
Secondary
- The progression-free survival (PFS)
- The overall survival(OS).
- The failed treatment modality.
- The toxicity of this regimen.
OUTLINE CCRT:Patients receive chemotherapy comprising Docetaxel(65mg/m2,iv gtt duration>1h) and Cisplatin(65mg/m2,concurrent hydration) on days 1 and 29 and at least 3 hours after chemotherapy undergo concurrent 3D-CRT five days a week for total dose 60-66Gy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age
- •untreated pathologically confirmed inoperable stage IIIA or IIIB NSCLC
- •weight loss of less than 10% in the past 6 months
- •performance status (PS) of 0 to 1
- •forced vital capacity in 1 second (FEV1) higher than 0.8 L
- •measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST).
- •absolute neutrophil count (ANC) of ≥ 1500/μL
- •hemoglobin ≥ 10 mg/dL
- •platelet ≥ 100,000/μL
- •serum creatinine ≤ 1.25 times of upper limit of normal (ULN)
- •calculated creatinine clearance (CrCl) of ≥ 60 ml/min
- •bilirubin 1.5×ULN
- •AST and ALT less than 2.5×ULN
- •alkaline phosphatase less than 5×ULN.
排除标准
- •active infection
- •history of significant cardiac disease (unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, ventricular arrhythmias)
- •malnutrition (loss of ≥ 20% of the original body weight)
- •sensor or motor neuropathy > grade I
- •second primary malignancy, except for non-melanoma skin cancer
- •psychiatric illness or social situation that would preclude study compliance
- •pregnant or lactating women
- •preexisting bleeding diatheses or coagulopathy
- •Prior chemotherapy,chest irradiation therapy, or therapy directed at the epidermal growth factor receptor pathway
研究组 & 干预措施
Endostatin combine CCRT
7.5mg/m2,iv gtt daily up to 7 days,beginning 1 week before radiotherapy,and repeat every 2 weeks
干预措施: Endostatin (Drug)
结局指标
主要结局
Response Rate (RR)
时间窗: 4 weeks after CCRT
Tumor response was evaluated with thoracic CT scans when CCRT was completed, in accordance with Response Evaluation Criteria in Solid Tumors Group (RECIST).
次要结局
未报告次要终点
研究者
Ming Chen
Professor
Sun Yat-sen University