Sequential Paclitaxel Chemotherapy and Radiotherapy as First Line Treatment for Elderly Metastatic Esophageal Squamous Cell Cancer:: a Phase II Single Center Prospective Clinical Trial
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
- progression free survival
研究概览
简要总结
Elderly patients with metastatic esophageal squamous cell carcinomas have poor prognosis and majority of them were intolerable to combined chemotherapy in China. In the investigators phase II clinical trial proceeded before, the paclitaxel treatment showed good tolerance and efficacy to esophageal squamous cell carcinomas. Radiotherapy has been indicated as a definitive treatment for unresectable or medically inoperable tumors in ESCC patients. However, not only the combination with chemotherapy, but also the boundaries of the clinical target volume (CTV) are not internationally defined. The investigators then initiated a prospective phase II clinical trial with sequential paclitaxel/cisplatin and radiotherapy as the 1st line treatment in elderly metastatic 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
- 69 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having signed informed consent Age more than 69 years old
- •Histologically confirmed esophageal squamous carcinoma,metastatic disease with primary tumor,no prior palliative chemotherapy;
- •No prior radiotherapy except radiotherapy at non-target lesion of the study more than 3 months
- •Sex is not limited
- •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 ≥80
- •Life expectancy of ≥ 3 month
- •WBC > 3,000/mm3, absolute neutrophil count ≥2000/mm3, platelet > 100,000/mm3, Hb > 9g/dl(within 14 days before enrollment),ALT and AST < 1.5 times ULN (≤5 times ULN in patients with liver metastases),Bilirubin level < 1.0 times ULN,Serum AKP < 2.5 times ULN,Serum creatinine < 1.0 times ULN
- •No sever complication, such as active gastrointestinal bleeding, perforation, jaundice, obstruction, non-cancerous fever > 38℃；
- •Normal ECG and heart function
- •Fertile patients must use effective contraception Good compliance
排除标准
- •Previous treatment of palliative chemotherapy
- •Known hypersensitivity to Paclitaxel,Cisplatin
- •Only with Brain or bone metastasis
- •No measurable lesions, eg. pleural fluid and ascites
- •Suffer from severe heart disease or disease with other important organs Chronic diarrhea or renal dysfunction
- •Other previous malignancy within 5 year, except non-melanoma skin cancer
- •Mentally abnormal or disable cognition,including CNS metastasis
结局指标
主要结局
progression free survival
时间窗: 1 year
the follow-up visit of PFS will be performed every 2 cycles
次要结局
- overall survival(2 years)
研究者
Shen Lin
Professor
Peking University