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

22 de marzo de 2022 actualizado 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.

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Descripción detallada

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 estudio

De observación

Inscripción (Actual)

531

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra de probabilidad

Población de estudio

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.

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
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.
Droga: Cetuximab
Weekly cetuximab at starting dose, that could be switched to biweekly
Droga: Paclitaxel
Paclitaxel at starting dose of 80 mg/m2

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Progression-free survival (PFS)
Periodo de tiempo: 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 resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Best Overall Response (BOR)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

18 de diciembre de 2020

Finalización primaria (Actual)

17 de enero de 2022

Finalización del estudio (Actual)

17 de enero de 2022

Fechas de registro del estudio

Enviado por primera vez

11 de diciembre de 2020

Primero enviado que cumplió con los criterios de control de calidad

11 de diciembre de 2020

Publicado por primera vez (Actual)

17 de diciembre de 2020

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

23 de marzo de 2022

Última actualización enviada que cumplió con los criterios de control de calidad

22 de marzo de 2022

Última verificación

1 de marzo de 2022

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

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

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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