Prospective, Open, Multicentre Phase I/II Study to Evaluate the Safety and Efficacy of a Neoadjuvant Radiochemotherapy With Docetaxel and Oxalipaltin in Patients With Adenocarcinoma of the Gastric-oesophageal Junction
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- maximum tolerable dose and safety
研究概览
简要总结
The purpose of this study is to determine the dose limiting toxicity and the maximum tolerable dose of the radiochemotherapy with Docetaxel and Oxaliplatin in patients with adenocarcinoma of the gastric-oesophageal junction.
详细描述
Radiotherapy starts on day 1 of chemotherapy after the application of Docetaxel and Oxaliplatin and will be administered in single doses of 1.8 Gy once daily and five times a week for 5 weeks.
In the sixth treatment week a boost of 3 further radiations with 1.8 Gy will be applied.
Simultaneous chemotherapy:
Initially, in part A of the study the maximum tolerable dose (MTD) for the simultaneous chemotherapy will be identified with a 3-step dose escalation scheme:
Level 1: Docetaxel: 20 mg/m2 Oxaliplatin 40 mg/m2 i.v., Level 2: Docetaxel: 20 mg/m2 Oxaliplatin 50 mg/m2 i.v., Level 3: Docetaxel: 25 mg/m2 Oxaliplatin 50 mg/m2 i.v.,
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adenocarcinoma of gastric-esophagal junction
- •stage II to III
- •unidimensional measurable disease
排除标准
- •surgery of primary tumor
- •metastasis
- •prior chemo- or radiotherapy
研究组 & 干预措施
one arm
干预措施: Docetaxel, Oxaliplatin (Drug)
one arm
干预措施: Radiotherapy (Procedure)
结局指标
主要结局
maximum tolerable dose and safety
时间窗: until August 2010
次要结局
未报告次要终点
研究者
PD Dr Markus Möhler
Professor
Johannes Gutenberg University Mainz