NCT00611507已完成2 期
A Phase II Study of Oxaliplatin in Association With 5FU and Folinic Acid in the Treatment of Subjects With Non-Surgical or Advanced Metastatic Gastric Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Response rate - RECIST criteria (unidimensional)
研究概览
简要总结
This phase II trial will evaluate, in first line advanced or metastatic gastric cancer, the efficacy and tolerance of another oxaliplatin, 5FU bolus combination already tested in advanced colorectal cancer
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
- •Histologically proven gastric or gastroesophagic junction adenocarcinoma
- •Measurable disease at least in a unidimensional manner. If a unique metastasis constitutes the only disease symptom, histological confirmation will be required
- •Metastatic or locally non-surgical primary gastric cancer
- •Recurrent gastric cancer after local and/or systemic treatment with a post-surgical period of at least 4 weeks, a post-adjuvant chemotherapy period or a neo-adjuvant chemo-radiotherapy of at least 6 months
- •Serum bilirubin< 2 mg/dl
- •Serum creatinine < or =to 2 times normal superior limit
- •Absolute neutrophil count > or =to 2000/dl
- •Platelet count > or =to 100000/dl
- •Hemoglobin > or =to 10 g/dl
- •AST/ALT < or =to 2.5 times normal superior institutional limit
- •Alkaline phosphatase < or =to 5 times the normal superior institutional limit
- •Age > 18 years
- •Performance Status ECOG 0-2
- •Written informed consent signed and dated
排除标准
- •Symptomatic sensory peripheral neuropathy
- •Uncontrolled concomitant disease.(e.g. severe diabetes mellitus, arterial hypertension)
- •Any other malignancy diagnosed within 5 years previous to the gastric cancer, with the exception of " in situ " cervix carcinoma or non-melanoma skin cancer
- •Concomitant anti-tumoral treatment
- •Cerebral metastases
- •Unstable heart disease, even though under treatment
- •Myocardial infarction within the last 6 months
- •Pregnancy or nursing (or women in reproductive life without adequate contraception)
- •Significant neurological or psychiatric disorders
结局指标
主要结局
Response rate - RECIST criteria (unidimensional)
时间窗: During the study conduct
次要结局
- Progression-free Survival (PFS)(During the study conduct)
研究者
研究点 (2)
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