XELOX With Capecitabine Maintenance or XELOX in Elderly Metastatic Adenocarcinoma of Stomach
2013年5月3日 更新者:BAI Yuxian、Harbin Medical University
A Randomized Single Center Phase II Study Comparing XELOX With Capecitabine Maintenance or XELOX Treatment in Elderly Metastatic Adenocarcinoma of Stomach
To confirm the efficacy and safety of XELOX with capecitabine maintenance in treatment of elderly advanced gastric cancer (AGC) by comparing it with that of XELOX regimen.
研究概览
详细说明
To investigate whether XELOX with capecitabine maintenance treatment as 1st line treatment in the elderly advanced gastric cancer is as effective and safe as XELOX regimen.
研究类型
介入性
注册 (预期的)
40
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。
学习地点
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Heilongjiang
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Harbin、Heilongjiang、中国、150000
- 招聘中
- The tumor hospital of Harbin medical university
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首席研究员:
- Yuxian BAI, PhD
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接触:
- Yuxian BAI, PhD
- 电话号码:86 451 86298265
- 邮箱:bai_yuxian@126.com
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接触:
- Hong SUI, PhD
- 电话号码:86 13936592698
- 邮箱:doctorsui2003@126.com
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副研究员:
- Hong SUI, PhD
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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
65年 及以上 (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:
- Ages Eligible for Study: 65 Years or older
- Genders Eligible for Study: Both
- The Eastern Cooperative Oncology Group (ECOG) status ≤ 2
- Histologically confirmed gastric adenocarcinoma(including LAUREN type).
- Measurable disease(according to the Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.1).
- chemotherapy naive after recurrence or metastasis. Previous neo-adjuvant or adjuvant treatment for gastric cancer, if applicable, more than 6 months.
- Hb > 90g/L, neutrophil count > or = 1.5*10^9/L, platelet > or = 100*10^9/L, alanine transaminase (ALT) and aspartate aminotransferase (AST) < or = 2.5 times upper limit of nominal (ULN), alkaline phosphatase (ALP) < or = 2.5 times ULN, total bilirubin (TBIL) < 1.5 times ULN, serum albumin level > or = 30g/L, serum creatinine < 1 times ULN.
- No serious concomitant diseases which could lead to death within 5 years. At least 5 years from the last Biological/Immunotherapy/Hormone treatment for Malignancy excluding gastric cancer.
- Able to accept oral medication
- Compliance with protocol
Exclusion Criteria:
- Had received cytotoxic chemotherapy, radiotherapy or immunotherapy for this gastric cancer, excluding Corticosteroids.
- Other previous malignancy within 5 year, except curative skin cancer or carcinoma in situ of uterine cervix.
- Uncontrolled epilepsy, central nervous system disorders, or a history of mental disorders.
- clinically significant(i.e. active)cardiac disease e.g. symptomatic coronary artery disease, New York Heart Association (NYHA) II or more serious congestive heart failure or severe requiring medication intervention arrhythmia, or history of myocardial infarction within the last 12 months.
- Upper gastrointestinal obstruction or physiological dysfunction or suffering from malabsorption syndrome, which could affect the absorption of capecitabine.
- Organ transplantation requires immunosuppressive treatment.
- Severe uncontrolled recurrent infections, or Other serious uncontrolled concomitant diseases.
- Moderate or severe renal impairment(creatinine clearance (CCr) = or < 50 ml/min), or serum creatinine > ULN.
- Known enzyme deficiency of dihydropyrimidine dehydrogenase(DPD).
- Allergy to Oxaliplatin or any study medication ingredients.
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:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:XELOX-X
XELOX: Oxaliplatin: 100mg/m2 d1 Intravenous infusion, every 3 weeks. Capecitabine: 850mg/m^2 bid, days 1-14, every 3 weeks and maximum 4 cycles, or progression/intolerance. X Maintenance: Capecitabine 850mg/m^2 bid, days 1-14, every 3 weeks after 4 cycles XELOX regimen, until progression/intolerance. |
Oxaliplatin 100mg/m2 d1 Intravenous infusion every 3 weeks
其他名称:
capecitabine 850mg/m2 bid, d1-14, every 3 weeks
其他名称:
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有源比较器:XELOX
XELOX: Oxaliplatin 100mg/m2 d1 Intravenous infusion, every 3 weeks.
Capecitabine 850mg/m^2 bid, days 1-14, every 3 weeks, until progression/intolerance.
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Oxaliplatin 100mg/m2 d1 Intravenous infusion every 3 weeks
其他名称:
capecitabine 850mg/m2 bid, d1-14, every 3 weeks
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 |
大体时间 |
---|---|
Progression Free Survival (PFS)
大体时间:From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
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From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 12 months
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次要结果测量
结果测量 |
大体时间 |
---|---|
总生存期(OS)
大体时间:从随机分组之日起至因任何原因死亡或最长 1 年
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从随机分组之日起至因任何原因死亡或最长 1 年
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不良事件(AE)
大体时间:从随机化日期到最后一次化疗后 28 天
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从随机化日期到最后一次化疗后 28 天
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Response Rate (RR)
大体时间:evaluate every 6 weeks after the date of randomization until diease progress or up to 12 weeks
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evaluate every 6 weeks after the date of randomization until diease progress or up to 12 weeks
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
health-related quality of life (HRQOL)
大体时间:evaluate every 6 weeks from the date of randomization until 28 days after the last chemo dosage
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evaluate every 6 weeks from the date of randomization until 28 days after the last chemo dosage
|
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excision repair cross-complementing 1(ERCC1) expression
大体时间:assays messager ribonucleic acid (mRNA) of ERCC1 expression in tumor tissue after randomization and before the first treatment
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quantitative real-time reverse transcriptase polymerase chain reaction (PCR) assays were performed to determine ERCC1 mRNA expression in tumor tissue.
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assays messager ribonucleic acid (mRNA) of ERCC1 expression in tumor tissue after randomization and before the first treatment
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K-ras gene type
大体时间:assess after randomization and before the first treatment
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Genomic Deoxyribonucleic acid (DNA) is extracted from tumor tissue, direct sequencing technique is used to test K-ras gene type(mutation or wild).
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assess after randomization and before the first treatment
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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:Yuxian BAI, PhD、The tumor hospital of Harbin medical 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12月1日
初级完成 (预期的)
2014年12月1日
研究完成 (预期的)
2015年12月1日
研究注册日期
首次提交
2012年12月13日
首先提交符合 QC 标准的
2013年2月22日
首次发布 (估计)
2013年2月25日
研究记录更新
最后更新发布 (估计)
2013年5月6日
上次提交的符合 QC 标准的更新
2013年5月3日
最后验证
2013年5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.
Oxaliplatin的临床试验
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Hospices Civils de Lyon未知