Weekly Cisplatin/Irinotecan and Radiotherapy in Patients With Locally Advanced Esophageal Cancer: Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- clinical complete response defined as no tumor detectable on esophagus endoscopy and no appearance of distant metastasis on CT scan
研究概览
简要总结
The standard non surgical therapy of locally advanced esophageal cancer is based on a definitive concurrent chemoradiotherapy regimen with fluorouracil and cisplatin. One of the alternative regimen which is being studied is the combination of a weekly cisplatin and irinotecan schedule with radiotherapy. This multicentric phase II clinical trial primarily aimed to evaluate the clinical complete response rate and secondary objectives were toxicity profile and survival.
详细描述
Chemotherapy with weekly cisplatin 30 mg/m2 AND Irinotecan 60 mg/m2 was administered at days1,8,22,29 and concurrently with radiotherapy t days 43,50,64,71. Radiotherapy was delivered day 43 to 75 with 50Gy in 25 fractions/5 weeks.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •esophageal carcinoma (squamous cell or adenocarcinoma) histologically confirmed
- •performance status <OR=2 (ECOG)
- •caloric intake>1500 KCal/d
- •serum albumin >32 gr/l
- •serum creatinine<120 microgr/l
- •total serum bilirubin < 1.5 mg/ml
- •no prior chemotherapy or radiotherapy or surgery for esophageal neoplasm
- •no prior history of malignancy other than cell carcinoma of the skin, in siyu cervical carcinoma, or head and neck carcinoma with complete response since 3 years
- •written informed consent
排除标准
- •Gilbert's syndrome
- •cardiac disease as NYHA class 3 or 4
- •myocardial infarction within the previous 6 months
- •metastatic disease
- •histologically proved invasion of tracheobronchial tree
- •metastatic disease
结局指标
主要结局
clinical complete response defined as no tumor detectable on esophagus endoscopy and no appearance of distant metastasis on CT scan
次要结局
- toxicity profile
- overall survival rate at one and two years