NCT02915965Unknown2 期
A Phase II Trial of Neoadjuvant Chemotherapy for Stage II, III Esophageal Squamous Cell Carcinoma
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2016年10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
- 80
- 试验地点
- 1
- 主要终点
- overall survival rate
研究概览
简要总结
The purpose of this study is to determine whether docetaxel, cisplatin, and capecitabine (DCX) are effective as the neoadjuvant chemotherapy before esophagectomy in patients with loco-regional esophageal squamous cell carcinoma (ESCC).
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage II or III, which is potentially resectable.
- •Patients must not have received any prior anticancer therapy.
- •More than 6 months of expected survival.
- •Age ranges from 18 to 70 years.
- •Absolute white blood cells count ≥4.0×109/L, neutrophil ≥1.5×109/L, platelets ≥100.0×109/L, hemoglobin ≥90g/L, and normal functions of liver and kidney.
- •Karnofsky performance status (KPS) of 90 or more.
- •Signed informed consent document on file.
排除标准
- •Patients are diagnosed or suspected to be allergic to docetaxol or cisplatin or capecitabine.
- •Patients with concomitant hemorrhagic disease.
- •Pregnant or breast feeding.
- •Inability to use gastric conduit after esophagectomy because of a prior surgery.
- •Patients with concomitant peripheral neuropathy, whose common toxicity criterion (CTC) status is 2 or even more.
- •Have a prior malignancy other than esophageal carcinoma, carcinoma in situ of the cervix, nonmelanoma skin cancer or cured early stage of prostate cancer.
研究组 & 干预措施
DCX and surgery
Experimental
docetaxol 60mg/m2 iv d1 and cisplatin 30mg/m2 iv d1-2 and capecitabine 850mg/m2 bid po d1-14 repeated every 21 days for 4-6 cycles, followed by surgery of Ivor Lewis Esophagectomy
干预措施: DCX (Drug)
DCX and surgery
Experimental
docetaxol 60mg/m2 iv d1 and cisplatin 30mg/m2 iv d1-2 and capecitabine 850mg/m2 bid po d1-14 repeated every 21 days for 4-6 cycles, followed by surgery of Ivor Lewis Esophagectomy
干预措施: surgery (Procedure)
结局指标
主要结局
overall survival rate
时间窗: 2 years
次要结局
- Pathologic response rate(2 years)
- Disease-free survival(2 years)
- Incidence of adverse event based on CTCAE 4.0(2 years)
研究者
Yanhong Deng
MD, PHD
Sun Yat-sen University
研究点 (1)
Loading locations...
相似试验
已完成
2 期
Efficacy of Docetaxel, Capecitabine, Cisplatin, and Bevacizumab in Patients With Unresectable Advanced Gastric CancerAdvanced Gastric CancerNCT01471470Asan Medical Center31
已完成
1 期
Docetaxel, Cisplatin, and Erlotinib Hydrochloride in Treating Patients With Stage I-III Non-small Cell Lung Cancer Following SurgeryRecurrent Lung Non-Small Cell CarcinomaStage IA Lung Non-Small Cell Carcinoma AJCC v7Stage IB Lung Non-Small Cell Carcinoma AJCC v7Stage IIA Lung Non-Small Cell Carcinoma AJCC v7Stage IIB Lung Non-Small Cell Carcinoma AJCC v7Stage IIIA Lung Non-Small Cell Cancer AJCC v7Stage IIIB Lung Non-Small Cell Cancer AJCC v7NCT00254384M.D. Anderson Cancer Center50
已完成
2 期
Phase II Study of Docetaxel Plus CDDP for NSCLC Stage IIINSCLCNCT00172380National Taiwan University Hospital41
已完成
2 期
A Multicenter Phase II Study of Neoadjuvant Docetaxel, Cisplatin and Capecitabine and Protocolized Surgery in Resectable Gastric CancerGastric CancerNCT01517009Jeroen Bosch Ziekenhuis50
Unknown
2 期
Induction Chemotherapy Followed by Concurrent Radiation With Cetuximab or Cisplatin in Locally Advanced Nasopharyngeal CancerNasopharyngeal CarcinomaNCT01614938Fudan University46