Maintenance Chemotherapy for Metastatic Colorectal Carcinoma and Biological Marker
Maintenance Chemotherapy for Metastatic Colorectal Carcinoma
研究概览
详细说明
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Age between 18 and 75 years Eastern Cooperative Oncology Group performance status (ECOG PS) 0-1 histologically confirmed colorectal cancer with inoperable locally advanced or recurrent and/or metastatic disease Life expectancy of at least 3 months Intact organ function, including complete blood counts (CBC) showing normal values or any toxicity limited to grade 1 and blood chemistry (SMA) showing liver and renal functions < 1.5 upper normal limit (UNL).
Patients who achieved objective response or stable disease after 16-24 weeks first line chemotherapy Signed informed consent
Exclusion Criteria:
- Known hypersensitivity to capecitabine Concurrent any other cancer (except BCC or squamous cell carcinoma of skin). Inability to adhere to monthly visits to the oncology unit for evaluation. Presence of brain metastases. Previous radiotherapy to the only site of measurable disease. Evidence of severe or uncontrolled systemic disease No previous chemotherapy for metastatic disease Positive serum pregnancy test in women of childbearing potential unresolved bowel obstruction or malabsorption syndrome
学习计划
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：三倍
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：Placebo
Placebo 1250mg/m2 tablet by mouth every 12 hours for 14 days
|
14 days
|
|
实验性的：Capecitabine
Capecitabine 1250mg/m2 tablet by mouth every 12 hours for 14 days
|
14days
|
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 |
|---|---|---|
|
DDC:Duration of Disease Control
大体时间：2 years
|
progression-free survival of first-line chemotherapy with second-line chemotherapy
|
2 years
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
OS:Overall Survival
大体时间：2 years
|
measured from the initiation of chemotherapy to the date of the last follow-up or death
|
2 years
|
|
DCR:Disease Control Rate
大体时间：2 years
|
This is defined as the occurrence of either a confirmed complete (CR),a partial response(PR)or stable disease(SD) as determined by the RECIST criteria from confirmed radiographic evaluations of target and non-target lesions.
|
2 years
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Safety
大体时间：2 years
|
Adverse events and laboratory tests graded according to the NCI-CTC AE Version 4.
|
2 years
|
合作者和调查者
调查人员
- 研究主任：Guangyu An, PhD、Beijing Chao Yang Hospital
研究记录日期
研究主要日期
初级完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
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.
placebo的临床试验
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City of Hope Medical CenterNational Cancer Institute (NCI)主动，不招人造血和淋巴细胞肿瘤 | 骨髓纤维化 | 慢性淋巴细胞白血病 | 缓解期成人急性髓性白血病 | 骨髓增生异常综合症 | 缓解期成人急性淋巴细胞白血病 | 骨髓增殖性肿瘤 | 慢性期慢性粒细胞白血病，BCR-ABL1 阳性 | 成人淋巴母细胞淋巴瘤 | 加速期慢性粒细胞白血病，BCR-ABL1 阳性 | HLA-A*0201 阳性细胞存在 | 巨细胞病毒感染 | 成人霍奇金淋巴瘤 | 成人非霍奇金淋巴瘤美国
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Mila (bMotion Technologies)完全的
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Universidad Autonoma de MadridCentro Universitario La Salle完全的