An Observational Study of First-Line Capecitabine Based Chemotherapy in Participants With Metastatic Colorectal Cancer (AXEL)
2017年2月17日 更新者：Hoffmann-La Roche
Program for Assessment of Capecitabine (Xeloda) Based First-line Therapies in Metastatic Colorectal Cancer (AXEL Study)
This observational study will evaluate the efficacy and safety of different capecitabine based chemotherapies, alone or in combination with other therapies, as first line treatment of metastatic colorectal cancer in participants during everyday clinical practice.
研究概览
研究类型
观察性的
注册 (实际的)
882
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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Budapest、匈牙利、1145
- Fövárosi Önkormányzat uzsoki utcai Kórház
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Budapest、匈牙利、1088
- Semmelweis Egyetem, II. Belgyogyaszati Klinika
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Budapest、匈牙利、1125
- Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika
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Budapest、匈牙利、1032
- Szent Margit Hospital
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Budapest、匈牙利、1076
- Fov.Onk.Peterfy S.Utcai Korh.-Rend.Int es Baleseti Kozp.
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Debrecen、匈牙利、4031
- Kenezy Korhaz Rendelointezet
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Gyor、匈牙利、9024
- Petz Aladar Megyei Oktato Korhaz
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Gyula、匈牙利、5700
- Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek
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Kecskemet、匈牙利、6000
- Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont
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Kistarcsa、匈牙利、2143
- Pest Megyei Flor Korhaz; Oncology
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Miskolc、匈牙利、3501
- Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly
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Nyíregyháza、匈牙利、4400
- Josa Andras Korhaz; Dept of Oncoradiology
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Pecs、匈牙利、7623
- Pécsi Tudományegyetem Áok; Onkoterapias Intezet
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Salgótarján、匈牙利、3100
- Szent Lázár Kórház
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Szeged、匈牙利、6720
- Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
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Szekesfehervar、匈牙利、8000
- Szent Gyorgy Korhaz;Fejer Megyei
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Szekszard、匈牙利、7100
- Tolna Megyei Onkormanyzat Balassa Janos Korhaz
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Szentes、匈牙利、6600
- Dr. Bugyi Istvan Korhaz
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Szombathely、匈牙利、9700
- Vas Megyei Markusovszky Korhaz X; Oncoradiology
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Tatabanuya、匈牙利、2800
- Szent Borbala Korhaz
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Veszprem、匈牙利、8200
- Veszprem Megyei Csolnoky; Ferenc Korhaz
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Zalaegerszeg、匈牙利、8900
- Zala megyei Önkormányzat Kórház és Rendelõintézet
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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 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Participants with newly diagnosed colorectal cancer who have started first-line capecitabine based chemotherapy alone or in combination with other therapies.
描述
Inclusion Criteria:
- Participants with newly diagnosed mCRC who have started first-line capecitabine-based chemotherapy in accordance with the current Hungarian label
Exclusion Criteria:
- History of serious or unexpected reaction to fluoropyrimidine therapy
- Hypersensitivity to the active ingredient of Xeloda or to any of the excipients of the product, or to fluorouracil
- Known dihydropyrimidine dehydrogenase deficiency
- Pregnancy or lactation
- Inadequate bone marrow, hepatic or renal function
- Treatment with sorivudine or its chemical analogues (for example, brivudine)
- If any contraindication for any drug used in the combination treatment schedules is present, the drug in question cannot be used
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
队列和干预
团体/队列 |
干预/治疗 |
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Metastatic Colorectal Carcinoma (mCRC) Participants
Newly diagnosed mCRC participants, who will receive first line capecitabine based chemotherapy according to effective official Summary of Product Characteristics, will be observed.
The choice of therapy is based exclusively on the medical decision of the treating physician before study enrollment.
The study protocol does not enforce treatment initiation and also do not specify any treatment regimen.
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First line capecitabine based oral tablet treatment in line with the effective Summary of Product Characteristics
其他名称：
First line chemotherapy according to effective official Summary of Product Characteristics.
The study protocol does not specify any particular therapy.
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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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Median Progression-free Survival (PFS)
大体时间：Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254
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PFS was assessed using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) and is defined as the time from the first dose of indicated treatment to disease progression (PD) or death, whichever occurred first.
Participants who did not progress or died while being followed were censored on the date of the last visit.
Participants without post-baseline tumor assessments were conservatively censored on the date of first study medication, which is PFS was assigned a value of 1 day.
PD: at least 20 percent (%) increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 millimeter (mm); progression of existing non-target lesions; or presence of new lesions.
Median PFS was estimated using Kaplan-Meier method.
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Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254
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PFS by Therapeutic Regimens
大体时间：Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254
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PFS was assessed using RECIST v1.1 and is defined as the time from the first dose of indicated treatment to PD or death, whichever occurred first.
Participants who did not progress or died while being followed were censored on the date of the last visit.
PD: at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm; progression of existing non-target lesions; or presence of new lesions.
Median PFS was estimated using Kaplan-Meier method.
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Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254
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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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Percentage of Participants With Overall Response as Assessed by Investigator Using RECIST v1.1
大体时间：Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254
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Overall response is defined as a complete response (CR) or a partial response (PR) as determined by the Investigator using RECIST v1.1 on 2 consecutive occasions at least 6 weeks apart.
Participants were evaluated for tumor response per RECIST v1.1 and assessed by computed tomography (CT) or magnetic resonance imaging (MRI):CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease.
All nodes, both target and non-target, must decrease to normal (short axis less than (<) 10 mm).
No new lesions.PR was defined as greater than or equal to (>=) 30% decrease under baseline of the sum of diameters of all target lesions.
The short axis was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions.
No unequivocal progression of non-target disease.
No new lesions.
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Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254
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Percentage of Participants With Clinical Benefit as Assessed Using RECIST v1.1
大体时间：Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254
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Clinical benefit was defined as having a confirmed CR, PR or stable disease (SD) for at least 24 weeks on study according to RECIST v1.1.CR: complete disappearance of all target lesions and non-target disease,with the exception of nodal disease.All nodes,both target and non-target, must decrease to normal (short axis <10 mm).No new lesions.PR: >=30% decrease under baseline of the sum of diameters of all target lesions.The short axis was used in the sum for target nodes,while the longest diameter was used in the sum for all other target lesions.No unequivocal progression of non-target disease.No new lesions.SD: neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD,taking as reference the smallest sum diameters while on study.PD:at least 20% increase in the sum of diameters of target lesions compared to the smallest sum of diameters on-study and absolute increase of at least 5 mm, progression of existing non-target lesions,or presence of new lesions.
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Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254
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Percentage of Participants Who Underwent Metastasectomy
大体时间：Baseline up to 1254 days
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Metastasectomy is the surgical removal of metastases, which are secondary cancerous growths that have spread from cancer originating in another organ in the body.
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Baseline up to 1254 days
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Mean Duration of Capecitabine Therapy
大体时间：Baseline up to 1254 days
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Baseline up to 1254 days
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Percentage of Participants With Dose Modification of Capecitabine
大体时间：Baseline up to 1254 days
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Baseline up to 1254 days
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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。
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
2011年7月1日
初级完成 (实际的)
2014年12月1日
研究完成 (实际的)
2014年12月1日
研究注册日期
首次提交
2012年9月27日
首先提交符合 QC 标准的
2012年9月27日
首次发布 (估计)
2012年10月1日
研究记录更新
最后更新发布 (实际的)
2017年3月23日
上次提交的符合 QC 标准的更新
2017年2月17日
最后验证
2017年2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.