NCT01752205Unknown3 期
A Randomized Phase III Study: Paclitaxel Plus Radiation Therapy With or Without Erlotinib in Treating Patients With Esophageal Squamous Carcinoma
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2012年11月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Progression free survival
研究概览
简要总结
The purpose of this study is to test the safety and effectiveness of erlotinib and chemoradiotherapy in patients with unresectable esophageal or gastro-esophageal squamous cancer .
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed squamous cell carcinoma of esophagus or Esophagogastric Junction
- •ECOG PS 0-2
- •Ineligibility for surgery
- •No prior palliative therapy
- •At least one bidimensionally measurable disease as defined by RECIST ver 1.1
- •Adequate organ function for treatment
- •Absolute neutrophil count (ANC)>=1000cells/mm3
- •Platelets >=100000 cells/mm3
- •Estimated creatinine clearance>=50mL/min, or serum creatinine<1.5 x institution upper limit of normal
- •Bilirubin=<1.5 x upper limit of normal(ULN)
- •AST(SGOT)=<2.5 x ULN (5.0xULN if hepatic metastases)
- •ALT(SGPT)=<2.5 x ULN (5.0xULN if hepatic metastases)
- •12-Lead electrocardiogram(ECG) with normal tracing or non-clinically significant changes that do not require medical intervention
- •QTc interval =<470 msec and without history of Torsades de Points or other symptomatic QTc abnormality
- •LVEF (by MUGA or echocardiogram) of >=50%.
- •The patient has provided signed informed consent and is amenable to compliance with protocol schedules and testing.
排除标准
- •Previous treatment with small molecule EGFR tyrosine kinase inhibitors
- •Any major operation within 4 weeks of baseline disease assessment
- •Any clinically significant gastrointestinal abnormalities which may impair intake or absorption of the study drug
- •CNS metastasis with continuous corticosteroid use within 4 weeks of baseline disease assessment
- •Patients with known interstitial lung disease
- •Patients with uncontrolled or significant cardiovascular disease (AMI within 12 months,Unstable angina within 6 months, NYHA Class III, IV Congestive heart failure or left ventricular ejection fraction below local institutional lower limit of normal or below 45%, Congenital long QT syndrome, Any significant ventricular arrhythmia, Any uncontrolled second or third degree heart block, Uncontrolled hypertension)
- •Previous or concurrent malignancy except for basal or squamous cell skin cancer and/or in situ carcinoma of the cervix, or other solid tumors treated curatively and without evidence of recurrence for at least 5 years prior to study entry.
- •Pregnant or breast-feeding women
- •Other severe acute or chronic medical condition or laboratory abnormality that may increase the risk associated with trial participation or investigational product administration or may interfere with the interpretation of trial results and, in the judgment of the investigator, would make the patient inappropriate for entry into this trial.
研究组 & 干预措施
Chemoradiotherapy
Active Comparator
The patients will receive radiation therapy QD, 5 days a week and receive paclitaxel IV ，dosing schedule: 45mg/m2/w.
干预措施: Paclitaxel (Drug)
Chemoradiotherapy
Active Comparator
The patients will receive radiation therapy QD, 5 days a week and receive paclitaxel IV ，dosing schedule: 45mg/m2/w.
干预措施: Radiation therapy (Radiation)
Erlotinib and chemoradiotherapy
Experimental
The patients will receive radiation therapy QD, 5 days a week and receive paclitaxel IV (45mg/m2/w) and erlotinib PO QD.
干预措施: Paclitaxel (Drug)
Erlotinib and chemoradiotherapy
Experimental
The patients will receive radiation therapy QD, 5 days a week and receive paclitaxel IV (45mg/m2/w) and erlotinib PO QD.
干预措施: Erlotinib (Drug)
Erlotinib and chemoradiotherapy
Experimental
The patients will receive radiation therapy QD, 5 days a week and receive paclitaxel IV (45mg/m2/w) and erlotinib PO QD.
干预措施: Radiation therapy (Radiation)
结局指标
主要结局
Progression free survival
时间窗: 2 year
次要结局
- Tumor response rate(1 year)
- disease control rate(1 year)
- overall survival(5 year)
- adverse events(5 year)
研究者
Xu jianming
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
The Affiliated Hospital of the Chinese Academy of Military Medical Sciences
研究点 (1)
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