NCT01044420Unknown2 期
mFOLFIRI as the Second Line Chemotherapy for Advanced Esophageal Carcinoma After Failure of 1st Line Treatment of Paclitaxel/DDP : a Phase II Single Center Prospective Clinical Trial
Peking University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2009年5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
- 50
- 试验地点
- 1
- 主要终点
- overall survival
研究概览
简要总结
There are few studies about 2nd line treatment in advanced esophageal carcinoma(AEC), some showed that irinotecan may be effective. The investigators previous study has shown the efficacy and safety of paclitaxel/cisplatin as 1st line treatment, so in this phase II study, the investigators would like to observe the efficacy and safety of Irinotecan/5FU/leucovorin as 2nd line treatment if AEC after failure to 1st treatment of PTX/DDP.
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,failed to 1st line treatment of paclitaxel/cisplatin
- •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
- •More than 1 Previous systemic therapy for metastatic esophageal squamous carcinoma
- •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
mFOLFIRI
Experimental
干预措施: mFOLFIRI (Drug)
结局指标
主要结局
overall survival
时间窗: 2 year
adverse events
时间窗: after each cycle of chemotherapy
次要结局
- progression-free survival(1year)
- response rate(every 6 weeks)
研究者
研究点 (1)
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