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

17 de fevereiro de 2017 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Tipo de estudo

Observacional

Inscrição (Real)

882

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

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

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
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.
Medicamento: Capecitabine
First line capecitabine based oral tablet treatment in line with the effective Summary of Product Characteristics
Outros nomes:
  • Xeloda
Medicamento: Chemotherapy
First line chemotherapy according to effective official Summary of Product Characteristics. The study protocol does not specify any particular therapy.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Median Progression-free Survival (PFS)
Prazo: 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
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Percentage of Participants With Overall Response as Assessed by Investigator Using RECIST v1.1
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Baseline up to 1254 days
Baseline up to 1254 days
Percentage of Participants With Dose Modification of Capecitabine
Prazo: Baseline up to 1254 days
Baseline up to 1254 days

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Hoffmann-La Roche

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo

1 de julho de 2011

Conclusão Primária (Real)

1 de dezembro de 2014

Conclusão do estudo (Real)

1 de dezembro de 2014

Datas de inscrição no estudo

Enviado pela primeira vez

27 de setembro de 2012

Enviado pela primeira vez que atendeu aos critérios de CQ

27 de setembro de 2012

Primeira postagem (Estimativa)

1 de outubro de 2012

Atualizações de registro de estudo

Última Atualização Postada (Real)

23 de março de 2017

Última atualização enviada que atendeu aos critérios de controle de qualidade

17 de fevereiro de 2017

Última verificação

1 de fevereiro de 2017

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • ML27791

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