A Phase II Study of Docetaxel and S-1 as First-line Chemotherapy in Patients With Advanced Esophageal Cancer
试验速览
- 阶段
- 2 期
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
This study will evaluate the efficacy of docetaxel and S-1 combination chemotherapy in Korean patients with esophageal cancer.
详细描述
Esophageal cancer is the ninth most common cancer in male population in Korea. It was estimated that 1,864 new cases of esophageal cancer were reported and 1,434 deaths occurred in Korea in 2005.
Although half of the patients with esophageal cancer initially present with locoregional disease amenable to radical surgery or radiation-based therapy, most patients eventually develop metastatic disease with or without local recurrence.
Chemotherapy plays a major role in palliative therapy and remains to be the primary mode of treatment for the recurrent or metastatic esophageal cancer. Although various chemotherapy regimens are available, esophageal cancer carries a very poor prognosis, with a mean survival time of less than 8.1 months with current chemotherapies used singly or in combination with 5-fluorouracil (5-FU), vindesine, mitomycin, docetaxel, paclitaxel, cisplatin, irinotecan, vinorelbine, or capecitabine. The majority of the trials performed were in small numbers of patients with reported response rates from 15 to 40%.
The response was usually of short duration and there was no survival benefit with single agent chemotherapy. Combination chemotherapy has slightly improved the results in terms of duration of response (3-6 months), but still there was little improvement in overall survival. Therefore, the identification of new active agents is essential to prolong the survival.
Clinical trials of single agent docetaxel have been reported in patients with esophageal cancer and the response rate is about 18-25%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
- •Pathologically confirmed squamous cell carcinoma or adenocarcinoma of esophagus.
- •Unresectable locally advanced, recurrent or metastatic disease.
- •Measurable or evaluable disease by RECIST criteria 1.
- •Minimum age of 18 years.
- •ECOG Performance status 0-
- •Prior chemotherapy is not allowed.
- •More than 4 weeks since completion of prior radiotherapy (measurable or evaluable lesions are outside the radiation field)
- •Adequate organ functions
- •Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital
排除标准
- •Other tumor type than squamous cell carcinoma and adenocarcinoma
- •Previous history of chemotherapy except neoadjuvant or adjuvant chemotherapy without docetaxel and S-1
- •Obvious bowel obstruction unrelieved by proper management
- •Evidence of serious gastrointestinal bleeding
- •Patients with CNS metastases
- •Patients with active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus, myocardial infarction during the preceding 6 months, pregnancy, or breast feeding
- •Any previous or concurrent malignancy other than non-melanoma skin cancer or in situ cancer of uterine cervix
- •Known history of cerebral or leptomeningeal metastases or neurologic disease
研究组 & 干预措施
DS (docetaxel+S-1)
Treatment will be delivered as a 3-week cycle.
- Docetaxel 60 mg/m²IV on day 1
- S-1 80 mg/m2/day PO on day 1-14
干预措施: DS (docetaxel+S-1) (Drug)
结局指标
主要结局
Objective response rate
时间窗: 1.5 years
Objective response rate will be measured from the rate of complete response (disappearance of disease) and partial response (decrease at least 30% in the sum of the longest diameters of target lesions) by RECIST (response evaluation criteria in solid tumors) guidelines.
次要结局
- Disease control rate(1.5 years)
- Progression free survival(1.5 years)
- Overall survival(1.5 years)
- Toxicity profiles(1.5 years)