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Cetuximab Plus Paclitaxel as First Line for Recurrent and/or Metastatic SCCHN: Real World Data.

22 de março de 2022 atualizado por: Grupo Español de Tratamiento de Tumores de Cabeza y Cuello

Retrospective Study With Cetuximab Plus Paclitaxel as First Line for Recurrent and/or Metastatic SCCHN (Squamous Cell Carcinoma of the Head and Neck): Real World Data.

Retrospective observational study that aims to collect real world data on the cetuximab plus paclitaxel regimen as first line treatment for recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN).

Assignment of a patient to a specific therapeutic strategy has been already decided in the past according to normal routine clinical practice; the decision to prescribe a specific treatment (between January 2012 and December 2018) was clearly dissociated from the decision to include a patient in the present study.

The investigators will retrospectively collect the information for 500 patients diagnosed with recurrent and/or metastatic SCCHN treated with a cetuximab plus paclitaxel regimen as first line for unresectable recurrent and/or metastatic disease, starting treatment with the defined cetuximab plus paclitaxel regimen, in 20 hospital members of the "Grupo Español de Tratamiento de Tumores de Cabeza y Cuello (TTCC)", who express consent to participate in the study or have not explicitly withheld consent for use of their data. The information from the patients' medical records will be collected through the online database of the TTCC Group.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

Retrospective observational study that aims to collect real world data on the cetuximab plus paclitaxel regimen as first line treatment for recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN) with the restriction that the data collection will only be clinical data from patients who received paclitaxel 80 mg/m2 as a starting dose with weekly cetuximab that could have been switched to biweekly during the maintenance phase.

The main objective will be to estimate the Progression-free survival (PFS) in patients treated with paclitaxel 80 mg/m2 as a starting dose, with weekly cetuximab that could have been switched to biweekly during the maintenance phase, as first line for recurrent and/or metastatic SCCHN.

Secondary objectives include:

To determine the Overall Response Rate (ORR), Best Overall Response (BOR), Disease Control Rate (DCR), overall survival (OS), duration of response (DoR), and safety in patients treated with the defined cetuximab plus paclitaxel regimen.

To evaluate the percentage of long disease-free survivors (defined as patients disease-free and alive at 2 years), and evaluate the percentage of long non-disease-free survivors (defined as patients not disease free, but alive at 2 years.

Analyses of patient outcomes by prognostic subgroups.

Tipo de estudo

Observacional

Inscrição (Real)

531

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

  • Espanha
      • Barcelona, Espanha, 08003
        • Hospital de Mar
      • Madrid, Espanha, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Espanha, 28040
        • Hospital Universitario Clinico San Carlos
      • Madrid, Espanha, 28007
        • Hospital Universitario Gregorio Marañón
    • Andalucia
      • Granada, Andalucia, Espanha, 18014
        • Hospital Universitario Virgen de las Nieves
      • Málaga, Andalucia, Espanha, 29010
        • Hospital Regional Universitario de Málaga
      • Sevilla, Andalucia, Espanha, 41014
        • Hospital Universitario Virgen de Valme
    • Aragon
      • Zaragoza, Aragon, Espanha, 50009
        • Hospital Universitario Miguel Servet
    • Cantabria
      • Santander, Cantabria, Espanha, 39008
        • Hospital Universitario Marqués de Valdecilla
    • Castilla La Mancha
      • Toledo, Castilla La Mancha, Espanha, 45004
        • Hospital Virgen de la Salud
    • Castilla Y Leon
      • Salamanca, Castilla Y Leon, Espanha, 37007
        • Hospital Universitario De Salamanca
    • Cataluña
      • Badalona, Cataluña, Espanha, 08916
        • Institut Catalá d'Oncologia (ICO) BADALONA
      • Girona, Cataluña, Espanha, 17007
        • Institut Català d'Oncologia (ICO) Girona
      • Hospitalet de Llobregat, Cataluña, Espanha, 08908
        • Hospital Duran i Reynalds (ICO-Hospitalet)
    • Comunitat Valenciana
      • Valencia, Comunitat Valenciana, Espanha, 46026
        • Hospital Universitario y Politécnico La Fe
    • Galicia
      • A Coruña, Galicia, Espanha, 15009
        • Centro Oncologico de Galicia
      • Lugo, Galicia, Espanha, 27003
        • Hospital Universitario Lucus Augusti
    • Islas Baleares
      • Palma De Mallorca, Islas Baleares, Espanha, 07120
        • Hospital Universitario Son Espases
    • Navarra
      • Pamplona, Navarra, Espanha, 31008
        • Complejo Hospitalario Navarra (PAMPLONA)
    • Tenerife
      • San Cristobal de la Laguna, Tenerife, Espanha, 38320
        • Hospital Universitario Canarias (TENERIFE)

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 de Probabilidade

População do estudo

Patients diagnosed with recurrent and/or metastatic SCCHN treated with a cetuximab plus paclitaxel regimen as first line for unresectable R/M disease, starting treatment with the defined cetuximab plus paclitaxel regimen, between January 2012 and December 2018 in 20 hospital members of the "Grupo Español de Tratamiento de Tumores de Cabeza y Cuello", who express consent to participate in the study or have not explicitly withheld consent for use of their data.

Descrição

Inclusion Criteria:

  • Patients with histologically confirmed recurrent and/or metastatic head and neck squamous-cell carcinoma including oral cavity, oropharynx, hypopharynx and larynx.

Note: Histological confirmation is required at the diagnosis of the primary. Not for recurrence and/or metastatic stages when radiological or clinical confirmation is valid

  • Patients who received at least one dose of both paclitaxel 80 mg/m2 as a starting dose with weekly cetuximab, that could have been switched to biweekly during the maintenance phase, as a first line regimen in recurrent and/or metastatic disease.
  • Start of first cycle of paclitaxel plus cetuximab between 1 January 2012, and 31 December 2018.
  • Aged ≥ 18 years at the time of diagnosis of R/M SCCHN.

  • Voluntary written consent, if applicable*

    • Note: Waiver of consent could be acceptable after all reasonable efforts and procedures have been followed and exhausted, and when an explicit refusal to sign the informed consent or refusal for use of data, or a revocation of consent by the patient has not been obtained.

Exclusion Criteria:

  • Patients with histologically confirmed R/M SCCHN, who have also an unknown primary tumor or nasopharyngeal cancer or a non-squamous head & neck cancer.
  • Patients who received the paclitaxel and cetuximab regimen for the first time in recurrent and/or metastatic disease as a second or subsequent line.
  • Eastern Cooperative. Oncology Group (ECOG) performance status > 2.

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
Recurrent and/or metastatic SCCHN
Patients who received at least one dose of both paclitaxel 80 mg/m2 as a starting dose with weekly cetuximab, that could have been switched to biweekly during the maintenance phase, as a first line regimen in recurrent and/or metastatic disease.
Medicamento: Cetuximab
Weekly cetuximab at starting dose, that could be switched to biweekly
Medicamento: Paclitaxel
Paclitaxel at starting dose of 80 mg/m2

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Progression-free survival (PFS)
Prazo: Through study completion, average 1 year
The PFS time is defined as the time from start of study treatment (first administration of cetuximab or paclitaxel) to the date of progression or death, whichever occurs first. In patients without a PFS event, the PFS time will be censored on the date of the last radiological evaluation or on the date of the last study treatment received if the tumor response has not been evaluated after start of study treatment. If no PFS was observed prior to start of second line treatment, then the PFS time will be censored at the first date of second line treatment.
Through study completion, average 1 year

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Best Overall Response (BOR)
Prazo: Through study completion, average 1 year
Best overall response during study treatment with the categories complete response (CR), partial response (PR), stable disease (SD), progressive disease (PD) or not available (NA), as assessed by the responsible physician. The method used to assess BOR (e.g. RECIST and version) will be also recorded.
Through study completion, average 1 year
Overall Response Rate (ORR)
Prazo: Through study completion, average 1 year
Overall response rate, defined as the proportion of patients with CR or PR as BOR.
Through study completion, average 1 year
Disease Control Rate (DCR)
Prazo: Through study completion, average 1 year
The proportion of patients with CR, PR or SD as BOR.
Through study completion, average 1 year
Frequency of Adverse Events (AEs)
Prazo: Through study completion, average 1 year
Safety will be studied as function of AEs frequency: The number of adverse events classified by type and intensity
Through study completion, average 1 year
Overall survival (OS)
Prazo: Through study completion, average 1 year
Defined as time from start of study treatment until date of death due to any cause. In patients without death the OS time is censored at the last date known to be alive.
Through study completion, average 1 year
Relative dose intensity (RDI)
Prazo: Through study completion, average 1 year
Relative dose intensity (RDI) defined as amount of drug administered per unit of time expressed as the fraction of that defined in the standard regimen
Through study completion, average 1 year
Dose-related and compliance data
Prazo: Through study completion, average 1 year
Frequency and magnitude of dose interruptions, dose modifications and discontinuation of treatment classified by the cause of discontinuation including adverse events, relapse, medical decision, patient decision, death and loss of follow-up.
Through study completion, average 1 year
Duration of Response (DOR)
Prazo: Through study completion, average 1 year

Defined as the time from the first occurrence of PR or CR as BOR until PD or death, whichever occurs first in patients with CR or PR as BOR.

The censoring rules specified for PFS will be also applied for duration of response.
Through study completion, average 1 year
Proportion of long disease-free survivors
Prazo: Through study completion, average 1 year
The proportion of patients alive and disease-free at 2 years after start of study treatment. Only disease-free patients under first line treatment should be counted.
Through study completion, average 1 year

Colaboradores e Investigadores

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

Patrocinador

Grupo Español de Tratamiento de Tumores de Cabeza y Cuello

Colaboradores

Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Investigadores

  • Investigador principal: Beatriz Cirauqui Cirauqui, M.D. Ph.D., Institut Catalá d'Oncologia (ICO) BADALONA
  • Investigador principal: Jordi Rubió Casadevall, M.D. Ph.D., Institut Català d'Oncologia (ICO) Girona

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 (Real)

18 de dezembro de 2020

Conclusão Primária (Real)

17 de janeiro de 2022

Conclusão do estudo (Real)

17 de janeiro de 2022

Datas de inscrição no estudo

Enviado pela primeira vez

11 de dezembro de 2020

Enviado pela primeira vez que atendeu aos critérios de CQ

11 de dezembro de 2020

Primeira postagem (Real)

17 de dezembro de 2020

Atualizações de registro de estudo

Última Atualização Postada (Real)

23 de março de 2022

Última atualização enviada que atendeu aos critérios de controle de qualidade

22 de março de 2022

Última verificação

1 de março de 2022

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • TTCC-2019-02
  • TTC-CET-2020-01 (Outro identificador: Agencia Española del Medicamento y Productos Sanitarios)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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