NCT01962246已完成2 期
Phase II Multi-Institutional Randomized Trial of Capecitabine Plus Oxaliplatin With Concurrent Radiotherapy in Patients With Potentially Resectable Adenocarcinoma of Gastroesophageal Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 169
- 试验地点
- 1
- 主要终点
- Disease-free survival(DFS)
研究概览
简要总结
Stage I：preoperative therapy
- Capecitabine plus oxaliplatin with concurrent radiotherapy is superior to surgery alone ; Stage II: Perioperative therapy
- Perioperative Capecitabine plus oxaliplatin with Concurrent radiotherapy is superior to adjuvant Capecitabine plus oxaliplatin alone;
- A regimen of Capecitabine plus oxaliplatin(XELOX) improves survival among patients with incurable locally advanced or metastatic adenocarcinoma of stomach and gastroesophageal cancer . The investigators assessed whether the addition of a perioperative regimen of XELOX regimen with concurrent radiotherapy to adjuvant alone improves R0 resection rate and survival among patients with curable locally advanced adenocarcinoma of stomach and gastroesophageal cancer
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Disease must be clinically limited to the esophagogastric junction, defined TypeⅡ TypeⅢ(From the endoscopic point of view according to the AEG criteria)
- •Histologically confirmed primary adenocarcinoma
- •T2-4 N0-3 M
- •T1 tumors are eligible if T1N1-3M0，
- •ECOG performance status ≦2
- •AEG is defined and described as tumors which have their center within 5cm proximal or distal of the anatomical cardia.
- •The classification of AEG type I, type II and type III AEG type I: adenocarcinoma of the distal esophagus,which usually arises from an area with specialized intestinal metaplasia of the esophagus, i Barrett's esophagus, and may infiltrate the esophago-gastric junction from above;
- •AEG type II: true carcinoma of the cardia, arising from the cardia epithelium or short segments with intestinal metaplasia at the esophago-gastric junction;
- •AEG type III: subcardial gastric carcinoma, which infiltrates the esophago-gastric junction and distal esophagus from below.
排除标准
- •Tis (in-situ carcinoma) and tumors determined to be TIN0 following endoscopy, endoscopic ultrasound and CT scanning.
- •Patients with primary carcinomas of the esophagus.
- •Prior chest or upper abdomen radiotherapy, prior systemic chemotherapy within the past 5 years, or prior esophageal or gastric surgery.
- •Patients with evidence of metastatic disease are not eligible.
- •Patients with a history of seizure disorder who are receiving phenytoin, phenobarbital, or other antiepileptic medication.
- •Patients who cannot fully comprehend the therapeutic implications of the protocol or comply with its requirements.
- •Patients with any medical or psychiatric condition or disease which, in the investigator's judgment, would make the patient inappropriate for entry into this study.
- •History of hypersensitivity to fluoropyrimidines, capecitabine, oxaliplatin or the ingredients of this product -
研究组 & 干预措施
postoperative chemotherapy,XELOX
Active Comparator
干预措施: Oxaliplatin; Capecitabine (Drug)
Preoperative Concurrent Chemoradiotherapy
Experimental
干预措施: Oxaliplatin; Capecitabine; concurrent radiotherapy (Other)
结局指标
主要结局
Disease-free survival(DFS)
时间窗: 3 year
次要结局
- R0-resection rate(within 3 weeks after surgery)
- Down-staging Rate(within 3 weeks after surgery)
- Adverse events(3 year)
- Death related to operation(4 weeks)
- Objective response rate (ORR)(within 3 weeks after surgery)
- Overall survival (OS)(3years)
- Disease control rate (DCR)(within 3 weeks after surgery)
研究者
Qun Zhao
Principal Investigator
Hebei Medical University
研究点 (1)
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