NCT00263354已完成2 期
Oxaliplatin Phase II Trial in Association With 5FU and Folinic Acid in the Treatment of Advanced Unresectable or 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
- 20
- 主要终点
- To evaluate response rate according to RECIST criteria
研究概览
简要总结
To determine the objective response to oxaliplatin/5FU/leucovorin combination chemotherapy in patients with advanced unresectable or metastatic 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ECOG performance status of 0-
- •Histologically proven gastric or gastro-esophageal junction adenocarcinoma.
- •At least unidimensional measurable disease. If a unique metastasis constitutes the only disease sign, it requires histological confirmation.
- •First line locally unresectable or metastatic gastric cancer.
- •Relapsing gastric cancer after local and/or systemic treatment with a post-surgical period of at least 4 weeks, a post-adjuvant or neoadjuvant chemoradiotherapy period of at least 6 months.
- •Serum bilirubin < 2 mg/dl
- •Serum creatinine < or = 2 mg/dl
- •Hemoglobin > or = 10 g/dl
- •Absolute neutrophil count > or = 2000/dl
- •Platelet count >or = 100, 000/dl
- •AST/ALT < or = 2.5 time-fold the institutional normal upper limit
- •Alkaline phosphatase < or = 5 time-fold the institutional normal upper limit
- •Imagenological evaluation of the patient at least 2 weeks prior to the drug infusion
- •Laboratory tests at least 1 week prior to the first infusion
- •Patient available for follow up and able to answer to the quality of life questionnaire
排除标准
- •Symptomatic sensorial peripheral neuropathy
- •Uncontrolled concomitant disease
- •Another malignant neoplastic disease diagnosed within the previous 5 years to the diagnosis of advanced or metastatic gastric cancer, with the exception of 'in situ' cervix carcinoma or non-melanoma skin cancer
- •Concomitant antitumoral treatment
- •Cerebral metastases
- •Unstable heart disease, even though in treatment
- •Myocardial infarction within the last 6 months
- •Radiotherapy within the last 6 weeks, surgery within the last 4 weeks, or chemotherapy 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
To evaluate response rate according to RECIST criteria
To evaluate the progression-free survival in the ITT population
次要结局
- To evaluate the overall survival in the ITT population
- To investigate safety using NCI-CTC criteria version 2
研究者
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