NCT00591045Unknown2 期
A Randomized Phase II Multicenter Controlled Study of Oxaliplatin, Calcium Folinate, and 5-Fluorouracil as Neoadjuvant Chemotherapy for Resectable Advanced Gastric Cancer
Peking University1 个研究点 分布在 1 个国家目标入组 263 人开始时间: 2008年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 263
- 试验地点
- 1
- 主要终点
- 5 year overall survival
研究概览
简要总结
This is a randomized phase II multicenter controlled study of oxaliplatin, calcium folinate, and 5-fluorouracil (mFOLFOX7) as neoadjuvant chemotherapy for resectable advanced gastric cancer.
Hypothesis: Neoadjuvant chemotherapy may improve 5 year overall survival compared with the control.
详细描述
The study hypothesis is that the 5 year survival rate will reach 35% from 25% when neoadjuvant chemotherapy is carried out. With the alpha value to be 0.05 and beta value to be 0.80 as well as 10 percent of patients' lost-of-followup, the sample size will be 263.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ECOG score 0-2
- •Ambulatory males or females, aged 30-70 years.
- •Histologically confirmed gastric adenocarcinoma, staged preoperatively AJCC/UICC stage III(T3N1,T2N2,T4N0,T3N2)and IVM0 and operable
- •Life expectancy more than 3 months
- •Give written informed consent prior to study specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time, without prejudice.
- •Normal hepatic, renal, and bone marrow function (GPT<2 fold of upper limit value; WBC>4000/dl, Tbil<1.5mg/dl, Cr<1.5 fold of upper limit value)
排除标准
- •Patients can not bear surgical procedure.
- •Pregnant or lactating women or women do not agree conceptive procedures.
- •Previous cytotoxic chemotherapy, radiotherapy or immunotherapy except corticosteroids, for the currently treated gastric cancer.
- •History of another malignancy within the last five years except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix.
- •History of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the Investigator to be clinically significant precluding informed consent or interfering with compliance for oral drug intake.
- •Clinically significant (i.e. active) cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) grade II or greater congestive heart failure or serious cardiac arrhythmia requiring medication or myocardial infarction within the last 12 months.
- •Organ allografts requiring immunosuppressive therapy.
- •Serious uncontrolled intercurrent infections or other serious uncontrolled concomitant disease.
- •Moderate or severe renal impairment: serum creatinine > 1.5 x upper limit of normal (ULN).
- •Prior unanticipated severe reaction to fluoropyrimidine therapy (with or without documented DPD deficiency) or patients with known dihydropyrimidine dehydrogenase (DPD) deficiency.
- •Hypersensitivity to platinum compounds or any of the components of the study medications.
- •Received any investigational drug or agent/procedure, i.e. participation in another trial, within 4 weeks before randomization.
- •Unwilling or unable to comply with the protocol for the duration of the study.
研究组 & 干预措施
1
Experimental
The patients will undergo neoadjuvant chemotherapy with mFOLFOX and then an operation and then individualized adjuvant chemotherapy.
干预措施: mFOLFOX (Drug)
结局指标
主要结局
5 year overall survival
时间窗: Jan 2008 to Dec 2012
次要结局
- R0 resection rate(Jan 2008 to Dec 2012)
研究者
研究点 (1)
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