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An Observational Study of First-Line Capecitabine Based Chemotherapy in Participants With Metastatic Colorectal Cancer (AXEL)

17. Februar 2017 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

882

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Ungarn
      • Budapest, Ungarn, 1145
        • Fövárosi Önkormányzat uzsoki utcai Kórház
      • Budapest, Ungarn, 1088
        • Semmelweis Egyetem, II. Belgyogyaszati Klinika
      • Budapest, Ungarn, 1125
        • Semmelweis Egyetem Aok; Iii.Sz. Belgyogyaszati Klinika
      • Budapest, Ungarn, 1032
        • Szent Margit Hospital
      • Budapest, Ungarn, 1076
        • Fov.Onk.Peterfy S.Utcai Korh.-Rend.Int es Baleseti Kozp.
      • Debrecen, Ungarn, 4031
        • Kenezy Korhaz Rendelointezet
      • Gyor, Ungarn, 9024
        • Petz Aladár Megyei Oktató Kórház
      • Gyula, Ungarn, 5700
        • Békés Megyei Pándy Kálmán Kórház; Onkologiai tanszek
      • Kecskemet, Ungarn, 6000
        • Bacs-Kiskun Megyei Korhaz, SZTE AOK Oktato Korhaza, Onkoradiologiai Kozpont
      • Kistarcsa, Ungarn, 2143
        • Pest Megyei Flor Korhaz; Oncology
      • Miskolc, Ungarn, 3501
        • Borsod-Abauj-Zemplen Megyei Korhaz Es Egyetemi Oktato Korhaz; Onkologiai Osztaly
      • Nyíregyháza, Ungarn, 4400
        • Josa Andras Korhaz; Dept of Oncoradiology
      • Pecs, Ungarn, 7623
        • Pécsi Tudományegyetem Áok; Onkoterapias Intezet
      • Salgótarján, Ungarn, 3100
        • Szent Lázár Kórház
      • Szeged, Ungarn, 6720
        • Szegedi Tudomanyegyetem, AOK, Szent-Gyorgyi Albert Klinikai Kozpont, Onkoterapias Klinika
      • Szekesfehervar, Ungarn, 8000
        • Szent Gyorgy Korhaz;Fejer Megyei
      • Szekszard, Ungarn, 7100
        • Tolna Megyei Onkormanyzat Balassa Janos Korhaz
      • Szentes, Ungarn, 6600
        • Dr. Bugyi Istvan Korhaz
      • Szombathely, Ungarn, 9700
        • Vas Megyei Markusovszky Korhaz X; Oncoradiology
      • Tatabanuya, Ungarn, 2800
        • Szent Borbala Korhaz
      • Veszprem, Ungarn, 8200
        • Veszprem Megyei Csolnoky; Ferenc Korhaz
      • Zalaegerszeg, Ungarn, 8900
        • Zala megyei Önkormányzat Kórház és Rendelõintézet

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

Participants with newly diagnosed colorectal cancer who have started first-line capecitabine based chemotherapy alone or in combination with other therapies.

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.
Arzneimittel: Capecitabine
First line capecitabine based oral tablet treatment in line with the effective Summary of Product Characteristics
Andere Namen:
  • Xeloda
Arzneimittel: Chemotherapy
First line chemotherapy according to effective official Summary of Product Characteristics. The study protocol does not specify any particular therapy.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Median Progression-free Survival (PFS)
Zeitfenster: Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254
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.
Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254
PFS by Therapeutic Regimens
Zeitfenster: Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254
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.
Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants With Overall Response as Assessed by Investigator Using RECIST v1.1
Zeitfenster: Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254
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.
Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254
Percentage of Participants With Clinical Benefit as Assessed Using RECIST v1.1
Zeitfenster: Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254
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.
Baseline until disease progression, death, unacceptable toxicity, or withdrawal of consent, whichever occurred first, evaluated up to Day 1254
Percentage of Participants Who Underwent Metastasectomy
Zeitfenster: Baseline up to 1254 days
Metastasectomy is the surgical removal of metastases, which are secondary cancerous growths that have spread from cancer originating in another organ in the body.
Baseline up to 1254 days
Mean Duration of Capecitabine Therapy
Zeitfenster: Baseline up to 1254 days
Baseline up to 1254 days
Percentage of Participants With Dose Modification of Capecitabine
Zeitfenster: Baseline up to 1254 days
Baseline up to 1254 days

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Hoffmann-La Roche

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Juli 2011

Primärer Abschluss (Tatsächlich)

1. Dezember 2014

Studienabschluss (Tatsächlich)

1. Dezember 2014

Studienanmeldedaten

Zuerst eingereicht

27. September 2012

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

27. September 2012

Zuerst gepostet (Schätzen)

1. Oktober 2012

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

23. März 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

17. Februar 2017

Zuletzt verifiziert

1. Februar 2017

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • ML27791

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