A Phase II Study of Icotinib With Concurrent Radiotherapy in Elderly Patients With Esophageal Cancer
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- all cause mortality
研究概览
简要总结
To investigate the efficacy and toxicity of EGFR tyrosine-kinase inhibitor (Icotinib) with concurrent radiotherapy in older patients with esophageal cancer.
详细描述
Older patients with esophageal cancer have been correlated with poor prognosis because of having little chance to receive aggressive local therapy, including surgery or concurrent chemoradiotherapy. EGFR is overexposed in most of the cases. In this phase II trial, the efficacy and toxicity of EGFR tyrosine-kinase inhibitor (Icotinib) with concurrent radiotherapy will be investigated in this setting.
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
- 70 Years 至 85 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed esophageal carcinoma
- •Stage I～Iva By EUS and CT/MRI, without contraindication for radical radiotherapy
- •Aged ≥ 70 and < 85 years, behavioral status evaluation ECOG scores 0-2
- •In 7 days after being screened, subjects should follow the status: WBC ≥ 3.0 x 10^9/L; ANC ≥ 1.5x 10^9/L; PLT ≥ 80 x 10^9/L; Hb ≥ 90 g/L; serum Cr ≤ ULN; serum bilirubin ≤ 1.5 ULN; ALT/AST ≤ 1.5 ULN
- •Subjects should sign for the informed consent
- •Subjects should perform good compliance
排除标准
- •Patients who have or are currently undergoing additional chemotherapy, radiation therapy or targeted therapy
- •Complete obstruction of the esophagus, or patients who have the potential to develop perforation
- •Patients with a history of malignancy (except that skin carcinomas or in situ breast cancer, oral cancer and cervical cancer with expected survival ≥2 years
- •Patients who have multiple foci esophageal carcinomas
- •Patients who are/were given any other medicine tests currently/in last 4 weeks
- •Experienced hypersensitiveness with similar medicine or other kinds of bio-medicines
- •Patients who have complications as following:
- •(1) Uncontrolled angina and heart failure, have a history of hospitalization in 3 months; (2) A history of myocardial infarction in the past 6 months; (3) There is a need for antibiotic treatment of acute bacterial or fungal infection; (4) Chronic obstructive pulmonary disease, or other lung disease requiring hospitalization; (5) Drug addiction, alcoholism and AIDS disease or long-term virus carriers; (6) Uncontrollable seizures, or loss of insight because of mental illness.
研究组 & 干预措施
Icotinib & Radiotherapy
Icotinib, 125mg, Po, Tid, during the course of radiotherapy; Thoracic radiotherapy, 50-60Gy, conventional fraction, 3D-CRT/IMRT.
干预措施: Icotinib (Drug)
Icotinib & Radiotherapy
Icotinib, 125mg, Po, Tid, during the course of radiotherapy; Thoracic radiotherapy, 50-60Gy, conventional fraction, 3D-CRT/IMRT.
干预措施: Thoracic radiotherapy (Radiation)
Radiotherapy alone
Thoracic radiotherapy alone, 50-60Gy, conventional fraction, 3D-CRT/IMRT.
干预措施: Thoracic radiotherapy (Radiation)
结局指标
主要结局
all cause mortality
时间窗: 2 years
次要结局
- incidence rates of radiation-related pneumonitis and esophagitis(within the 3 months after the initiation of RT)