A Phase II Trial of Exploring the Predictive Factors of TX and XELOX Regimen in the First Line Treatment of MGC
2013年10月12日 更新者：Xiaodong Zhu、Fudan University
Phase II Trial of Exploring the Predictive Factors of Docetaxol Plus Capecitabine(TX) Regimen and Oxaliplatin Plus Capecitabine (XELOX) Regimen in the First Line Treatment of Patients With Metastatic Gastric Cancer (MGC)
Platinum, fluorouracil and taxane based regimen are all acceptable in the first line treatment of metastatic gastric cancer.
The TX and XELOX regimen are two common regimen used in MGC.
whichever regimen is used, the average response rate is less than 50%.
So a rather part of patients can't get benefit from the treatment.
It is urgent to find out the predictive factors of these regimens in order to get a higher response and better survival outcome.
研究概览
详细说明
Patients with MGC will be treated with TX or XELOX regimen.
Before treatment, 14 days after treatment and after progression, the blood sample will be collected.
Primary tumor blocks will also of collected.
These samples will be used to detect predictive factors of the two types first line therapy.
研究类型
介入性
注册 (预期的)
120
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：xiaodong Zhu, M.D
- 电话号码：5000 +862164175590
- 邮箱：xddr001@163.com
学习地点
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Shanghai
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Shanghai、Shanghai、中国、200032
- 招聘中
- Fudan University Cancer Hospital
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接触：
- xiaodong Zhu, M.D
- 电话号码：5000 +862164175590
- 邮箱：xddr001@163.com
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 75年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Chemo-naive patients with metastatic, unresectable, histologically confirmed gastric or Gastroesophageal adenocarcinoma; Patients who received adjuvant chemotherapy, the duration from the last therapy to relapse at least longer than 6 months
- Patient must have at least one measurable lesions (RECIST 1.1)
- 18 Years to 75 years
- Written informed consent obtained
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1
- Patients must have adequate organ and marrow function as defined below:
- neutrophilicgranulocyte greater than/equal to 1,500/mm3;
- platelets greater than/equal to 90,000/ mm3;
- hemoglobin greater than/equal to 9 gm/dL (may be transfused to maintain or exceed this level);
- total bilirubin less than/equal to 1.5 within institutional upper limit of normal (IULN);
- Aspartate Transaminase (AST,SGOT)/Alanine transaminase (ALT,SGPT) less than/equal to 2.5 times IULN
- serum creatinine less than/equal to 1.5 x IULN.
Exclusion Criteria:
- Active clinically serious infections (> grade 2 NCI-CTC version 3.0, National Cancer Institute-Common Terminology Criteria for Adverse Events)
- Symptomatic metastatic brain or meningeal tumors
- History of organ allograft
- Patients undergoing renal dialysis
- chronic inflammatory bowel disease; ileus; genetic fructose intolerance
- Patients who received adjuvant chemotherapy and the duration from the last therapy less than 6 months
- Receive previously radiotherapy in measurable regions
- Pregnancy or lactating status
- Concurrent malignancy other than nonmelanoma skin cancer, or in situ cervix carcinoma
- Clinically relevant coronary artery disease or history of a myocardial infarction within the last 12 months
- Acute or subacute intestinal occlusion or history of the inflammatory bowel disease
- Any factors that influence the usage of oral administration
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Docetaxol ＆Capecitabine (TX)
Docetaxol: 75 mg/m2 d1, (From MAY 15th 2013, the dose was reduced to 60mg/m2 for high incidence of G3/4 myelosuppression after approved by institute Ethics Committee) ; Capecitabine 1000 mg/m2 bid ×14d; Repeat every 3 weeks, until disease progression or intolerable toxicity or patients withdrawal of consent,or total 8 cycles
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其他名称：
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有源比较器：Oxaliplatin ＆Capecitabine (XELOX)
Oxaliplatin: 130 mg/m2 d1; Capecitabine 1000 mg/m2 bid ×14d; Repeat every 3 weeks, until disease progression or intolerable toxicity or patients withdrawal of consent,or total 8 cycles
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其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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objective response
大体时间：6 weeks
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RECIST 1.1 (Response Evaluation Criteria in Solid Tumors) will be used to evaluate the response of each patient every 6 weeks.
The main purpose of this study is to search for the biomarkers which will predict the response of patients with MGC received TX or XELOX regimen as first line therapy
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6 weeks
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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progression free survival (PFS)
大体时间：From randomization until first documented progression or date of death from any cause, whichever came first (up to 60 months)
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PFS is defined as from the date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months
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From randomization until first documented progression or date of death from any cause, whichever came first (up to 60 months)
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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overall survival(OS)
大体时间：from the date of randomization until the date of death from any cause, assessed up to 60 months
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OS is defined as from the date of randomization until the date of death from any cause, assessed up to 60 months
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from the date of randomization until the date of death from any cause, assessed up to 60 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Jin Li, M.D / Ph.D、Fudan University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2012年8月1日
初级完成 (预期的)
2013年12月1日
研究完成 (预期的)
2014年12月1日
研究注册日期
首次提交
2013年10月9日
首先提交符合 QC 标准的
2013年10月12日
首次发布 (估计)
2013年10月16日
研究记录更新
最后更新发布 (估计)
2013年10月16日
上次提交的符合 QC 标准的更新
2013年10月12日
最后验证
2013年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
奥沙利铂的临床试验
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