NCT00237900终止1 期
An Open, Single.Centre, Phase I/II Study of ZD1839 (Iressa) in Combination With 5-Fluorouracil, Leucovorin and Radiotherapy in Subjects With Resectable Gastric Cancer
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Part 1: Safety and tolerability of gefitinib 250 mg in combination with radiotherapy (incidence of DLTs)
研究概览
简要总结
To assess safety, efficacy and explorative objectives of gefitinib in combination with chemoradiation in resectable gastric cancer
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
- 45 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically-confirmed intestinal GC (T2-T4)
- •Local or locally advanced stage II or stage III gastric cancer of an upper part of the stomach or GE junction
- •Lymph node positive or negative
- •Metastasis negative
- •Resection with curative intent (R0, D2)
- •Chemo- and radiotherapy naïve
- •Measurable lesion according RECIST
- •Written informed consent
排除标准
- •Aged below 45 or over 70
- •Prior gastric surgery
- •Active ILD
结局指标
主要结局
Part 1: Safety and tolerability of gefitinib 250 mg in combination with radiotherapy (incidence of DLTs)
Parts 2 and 3: Safety and tolerability of gefitinib in combination with 5-FU, LV and radiotherapy
次要结局
- Parts 2 and 3:
- Objective tumour response rate a week before surgery (CR and PR, RECIST criteria).
- Objective histological response rate in dissected GC specimens taken at surgery, estimated using Evans/Pisters scores
- Exploratory outcome: Parts 2 and 3: sVEGF levels, EGFR activation, Biomarkers such as cyclin D1, IL-1, GI-associated TOP2A, GAS, EST AA552509
研究者
研究点 (1)
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