NCT01051765Unknown2 期
Irinotecan Combined With Cisplatin as 1st Line Treatment for Esophageal Squamous Cell Cancer : a Single Center Prospective Clinical Trial
Peking University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
Irinotecan, as one new agent used in advanced esophageal carcinoma, has been shown to be effective and safe in western studies. Different with westerns, squamous carcinoma is the main pathological type in china patients. The investigators then initiated a prospective phase II clinical trial with irinotecan/cisplatin as the 1st line treatment in advanced esophageal carcinoma to observe the efficacy and safety of the combination.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having signed informed consent
- •Age 18 to 70 years old
- •Histologically confirmed esophageal squamous carcinoma, no prior palliative chemotherapy; recurrence from last adjuvant chemotherapy or adjuvant radiotherapy should be longer than 6 months; no prior treatment of irinotecan as adjuvant chemotherapy, total dose of cisplatin is less than 300mg/m2 if used in adjuvant chemotherapy
- •Unresectable recurrent or metastatic disease
- •Measurable disease according to the RECIST criteria(diameter of the lesion should be more than 10mm by spiral CT or MRI, more than 20mm by common CT, the date of image should be less than 15 days before enrollment)
- •Karnofsky performance status ≥70
- •Life expectancy of ≥3 month
- •No prior radiotherapy except radiotherapy at non-target lesion of the study more than 4 weeks
- •ALT and AST<2.5 times ULN (≤5 times ULN in patients with liver metastases)(within 7 days before enrollment)
- •Serum AKP < 2.5 times ULN (within 7 days before enrollment)
- •Serum creatinine <1.0 times ULN (within 7 days before enrollment)
- •Bilirubin level < 1.0 times ULN (within 7 days before enrollment)
- •WBC>4,000/mm3, absolute neutrophil count ≥2000/mm3, platelet>100,000/mm3, Hb>9g/dl(within 7 days before enrollment)
- •No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever>38℃；
- •Good compliance
排除标准
- •previous treatment of palliative chemotherapy or recurrence less than 6 months from time of last adjuvant chemo-/radiotherapy
- •Known hypersensitivity to irinotecan
- •Only with Brain or bone metastasis
- •Tumor with length≥10cm, liver metastasis covers more than 50% of liver,or lung metastasis covers more than 25% of lung
- •No measurable lesions, eg. pleural fluid and ascites
- •Surgery (excluding diagnostic biopsy) within 4 weeks prior to study entry
- •Heart failure or other sever organ dysfunction, eg. coronary artery disease, myocardial infarction within the last 6 months or
- •Pregnancy or lactation period
- •Other previous malignancy within 5 year, except non-melanoma skin cancer
- •Chronic diarrhea
- •Mentally abnormal or disable cognition,including CNS metastasis
研究组 & 干预措施
irinotecan/cisplatin
Experimental
irinotecan 130mg/m2 d1 cisplatin: 30mg/m2, d1,d2 every three weeks
干预措施: irinotecan/cisplatin (Drug)
结局指标
主要结局
overall survival
时间窗: 2 year
次要结局
- PFS(1year)
- response rate(1.5 months)
- adverse events(2 year)
- polymorphism of UGT1A(2 year)
研究者
研究点 (1)
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