NCT01517009已完成2 期
A Multicenter Phase II Study of Neoadjuvant Docetaxel, Cisplatin and Capecitabine and Protocolized Surgery in Resectable Gastric Cancer
Jeroen Bosch Ziekenhuis10 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2008年6月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 10
- 主要终点
- The number of patients with (serious) adverse events receiving the combination of 4 courses of docetaxel, cisplatin and capecitabine as neoadjuvant chemotherapy and standardized surgery in resectable localized or locally advanced gastric cancer.
研究概览
简要总结
The purpose of this study is to determine the feasibility of chemotherapy, consisting of docetaxel, cisplatin and capecitabine given prior to surgery for stomach cancer. Furthermore, an extended type of removal of lymph nodes will be implemented.
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
- •Ib-IVa histological proven resectable gastric adenocarcinoma, including gastro-oesophageal junction/cardia carcinoma Siewert 2 and 3
- •ASA 2 or less
- •Age 18 years or more
- •No prior radio- or chemotherapy conflicting with the treatment of gastric cancer
- •Haematology/Renal function/Liver function within designated range
- •Patient's consent form obtained, signed and dated before beginning specific protocol procedures
- •absence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial
- •before patient registration/randomization, written informed consent must be given according to GCP, WMO and local regulations.
排除标准
- •Previous or other current malignancies, with the exception of adequately treated in situ carcinoma of the cervix uteri or non-melanoma skin cancer
- •Other current serious illness or medical conditions
- •Severe cardiac illness (NYHA class III-IV)
- •Significant neurologic or psychiatric disorders
- •Uncontrolled infections
- •Active DIC
- •Other serious underlying medical conditions that could impair the ability of the patient to participate in the study
- •Known hypersensitivity to docetaxel (or any drug formulated with Polysorbate-80), or cisplatin or capecitabine or 5-FU
- •Definite contraindications for the use of corticosteroids
- •Use of immunosuppressive or antiviral drugs
- •Any other experimental drugs within a 4-week period prior to start of neoadjuvant chemotherapy and throughout the study period
- •Pregnant or lactating women
- •Patients with reproductive potential not implementing adequate contraceptive measures
结局指标
主要结局
The number of patients with (serious) adverse events receiving the combination of 4 courses of docetaxel, cisplatin and capecitabine as neoadjuvant chemotherapy and standardized surgery in resectable localized or locally advanced gastric cancer.
时间窗: 18 weeks
Patients receive every 3 weeks a cycle of chemotherapy, in total 4 cylcles will be given. Surgery will be performed approximately 6 weeks after the last cycle.
次要结局
- The number of patients receiving a D1-extra-resection as protocolized surgery in resectable gastric cancer(30 days)
研究者
Anneriet Dassen
Ms A.E. Dassen, MD, Principle Investigator
Jeroen Bosch Ziekenhuis
研究点 (10)
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