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.
調査の概要
研究の種類
観察的
入学 (実際)
882
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Budapest、ハンガリー、1145
- Fövárosi Önkormányzat uzsoki utcai Kórház
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Budapest、ハンガリー、1088
- Semmelweis Egyetem, Ii. Belgyogyaszati Klinika
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Budapest、ハンガリー、1125
- Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika
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Budapest、ハンガリー、1032
- Szent Margit Hospital
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Budapest、ハンガリー、1076
- Fov.Onk.Peterfy S.Utcai Korh.-Rend.Int es Baleseti Kozp.
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Debrecen、ハンガリー、4031
- Kenezy Korhaz Rendelointezet
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Gyor、ハンガリー、9024
- Petz Aladar Megyei Oktato Korhaz
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Gyula、ハンガリー、5700
- Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek
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Kecskemet、ハンガリー、6000
- Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont
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Kistarcsa、ハンガリー、2143
- Pest Megyei Flor Korhaz; Oncology
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Miskolc、ハンガリー、3501
- Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly
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Nyíregyháza、ハンガリー、4400
- Josa Andras Korhaz; Dept of Oncoradiology
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Pecs、ハンガリー、7623
- Pécsi Tudományegyetem Áok; Onkoterapias Intezet
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Salgótarján、ハンガリー、3100
- Szent Lázár Kórház
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Szeged、ハンガリー、6720
- Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
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Szekesfehervar、ハンガリー、8000
- Szent Gyorgy Korhaz;Fejer Megyei
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Szekszard、ハンガリー、7100
- Tolna Megyei Onkormanyzat Balassa Janos Korhaz
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Szentes、ハンガリー、6600
- Dr. Bugyi Istvan Korhaz
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Szombathely、ハンガリー、9700
- Vas Megyei Markusovszky Korhaz X; Oncoradiology
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Tatabanuya、ハンガリー、2800
- Szent Borbala Korhaz
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Veszprem、ハンガリー、8200
- Veszprem Megyei Csolnoky; Ferenc Korhaz
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Zalaegerszeg、ハンガリー、8900
- Zala megyei Önkormányzat Kórház és Rendelõintézet
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
Participants with newly diagnosed colorectal cancer who have started first-line capecitabine based chemotherapy alone or in combination with other therapies.
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
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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
他の名前：
First line chemotherapy according to effective official Summary of Product Characteristics.
The study protocol does not specify any particular therapy.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Median Progression-free Survival (PFS)
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
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Percentage of Participants With Overall Response as Assessed by Investigator Using RECIST v1.1
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Baseline up to 1254 days
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Baseline up to 1254 days
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2011年7月1日
一次修了 (実際)
2014年12月1日
研究の完了 (実際)
2014年12月1日
試験登録日
最初に提出
2012年9月27日
QC基準を満たした最初の提出物
2012年9月27日
最初の投稿 (見積もり)
2012年10月1日
学習記録の更新
投稿された最後の更新 (実際)
2017年3月23日
QC基準を満たした最後の更新が送信されました
2017年2月17日
最終確認日
2017年2月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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