- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01696695
An Observational Study of First-Line Capecitabine Based Chemotherapy in Participants With Metastatic Colorectal Cancer (AXEL)
2017년 2월 17일 업데이트: 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.
연구 개요
연구 유형
관찰
등록 (실제)
882
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Budapest, 헝가리, 1145
- Fövárosi Önkormányzat uzsoki utcai Kórház
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Budapest, 헝가리, 1088
- Semmelweis Egyetem, II. Belgyógyászati Klinika
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Budapest, 헝가리, 1125
- Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika
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Budapest, 헝가리, 1032
- Szent Margit Hospital
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Budapest, 헝가리, 1076
- Fov.Onk.Peterfy S.Utcai Korh.-Rend.Int es Baleseti Kozp.
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Debrecen, 헝가리, 4031
- Kenezy Korhaz Rendelointezet
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Gyor, 헝가리, 9024
- Petz Aladar Megyei Oktato Korhaz
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Gyula, 헝가리, 5700
- Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek
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Kecskemet, 헝가리, 6000
- Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont
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Kistarcsa, 헝가리, 2143
- Pest Megyei Flor Korhaz; Oncology
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Miskolc, 헝가리, 3501
- Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly
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Nyíregyháza, 헝가리, 4400
- Josa Andras Korhaz; Dept of Oncoradiology
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Pecs, 헝가리, 7623
- Pécsi Tudományegyetem Áok; Onkoterapias Intezet
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Salgótarján, 헝가리, 3100
- Szent Lázár Kórház
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Szeged, 헝가리, 6720
- Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
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Szekesfehervar, 헝가리, 8000
- Szent Gyorgy Korhaz;Fejer Megyei
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Szekszard, 헝가리, 7100
- Tolna Megyei Onkormanyzat Balassa Janos Korhaz
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Szentes, 헝가리, 6600
- Dr. Bugyi Istvan Korhaz
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Szombathely, 헝가리, 9700
- Vas Megyei Markusovszky Korhaz X; Oncoradiology
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Tatabanuya, 헝가리, 2800
- Szent Borbala Korhaz
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Veszprem, 헝가리, 8200
- Veszprem Megyei Csolnoky; Ferenc Korhaz
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Zalaegerszeg, 헝가리, 8900
- Zala megyei Önkormányzat Kórház és Rendelõintézet
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
Participants with newly diagnosed colorectal cancer who have started first-line capecitabine based chemotherapy alone or in combination with other therapies.
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
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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
다른 이름들:
First line chemotherapy according to effective official Summary of Product Characteristics.
The study protocol does not specify any particular therapy.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Median Progression-free Survival (PFS)
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Percentage of Participants With Overall Response as Assessed by Investigator Using RECIST v1.1
기간: 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
기간: 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
기간: 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
기간: 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
기간: Baseline up to 1254 days
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Baseline up to 1254 days
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2011년 7월 1일
기본 완료 (실제)
2014년 12월 1일
연구 완료 (실제)
2014년 12월 1일
연구 등록 날짜
최초 제출
2012년 9월 27일
QC 기준을 충족하는 최초 제출
2012년 9월 27일
처음 게시됨 (추정)
2012년 10월 1일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2017년 3월 23일
QC 기준을 충족하는 마지막 업데이트 제출
2017년 2월 17일
마지막으로 확인됨
2017년 2월 1일
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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Capecitabine에 대한 임상 시험
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Hebei Medical University알려지지 않은
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Assistance Publique - Hôpitaux de Paris모집하지 않고 적극적으로