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

22 mars 2022 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

531

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans et plus (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon de probabilité

Population étudiée

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.

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Intervention / Traitement
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.
Médicament: Cetuximab
Weekly cetuximab at starting dose, that could be switched to biweekly
Médicament: Paclitaxel
Paclitaxel at starting dose of 80 mg/m2

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Progression-free survival (PFS)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Best Overall Response (BOR)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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)
Délai: 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
Délai: 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)
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Grupo Español de Tratamiento de Tumores de Cabeza y Cuello

Collaborateurs

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

Les enquêteurs

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

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Réel)

18 décembre 2020

Achèvement primaire (Réel)

17 janvier 2022

Achèvement de l'étude (Réel)

17 janvier 2022

Dates d'inscription aux études

Première soumission

11 décembre 2020

Première soumission répondant aux critères de contrôle qualité

11 décembre 2020

Première publication (Réel)

17 décembre 2020

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

23 mars 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

22 mars 2022

Dernière vérification

1 mars 2022

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

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

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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