Clinical trial NCT04672772: Cetuximab Plus Paclitaxel as First Line for Recurrent and/or Metastatic SCCHN: Real World Data.
Official title: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Squamous Cell Carcinoma of the Head and Neck
Keywords: Cetuximab
Paclitaxel
recurrent and/or metastatic
retrospective observational study
Squamous Cell Carcinoma of Head and Neck
Lead sponsor: Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
Sponsor class: OTHER
Collaborators: name: Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
First posted: 2020-12-17
Enrollment: 531
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Progression-free survival (PFS)
timeFrame: Through study completion, average 1 year
Secondary outcomes:
measure: Best Overall Response (BOR)
timeFrame: Through study completion, average 1 year
measure: Overall Response Rate (ORR)
timeFrame: Through study completion, average 1 year
measure: Disease Control Rate (DCR)
timeFrame: Through study completion, average 1 year
measure: Frequency of Adverse Events (AEs)
timeFrame: Through study completion, average 1 year
measure: Overall survival (OS)
timeFrame: Through study completion, average 1 year
measure: Relative dose intensity (RDI)
timeFrame: Through study completion, average 1 year
measure: Dose-related and compliance data
timeFrame: Through study completion, average 1 year
measure: Duration of Response (DOR)
timeFrame: Through study completion, average 1 year
measure: Proportion of long disease-free survivors
timeFrame: Through study completion, average 1 year
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
state: Andalucia
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga
state: Andalucia
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de Valme
state: Andalucia
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
state: Aragon
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla
state: Cantabria
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud
state: Castilla La Mancha
city: Salamanca
country: Spain
facility: Hospital Universitario de Salamanca
state: Castilla Y Leon
city: Badalona
country: Spain
facility: Institut Catalá d'Oncologia (ICO) Badalona
state: Cataluña
city: Girona
country: Spain
facility: Institut Catalá d'Oncologia (ICO) Girona
state: Cataluña
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Duran i Reynalds (ICO-Hospitalet)
state: Cataluña
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico La Fe
state: Comunitat Valenciana
city: A Coruña
country: Spain
facility: Centro Oncológico de Galicia
state: Galicia
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
state: Galicia
city: Palma De Mallorca
country: Spain
facility: Hospital Universitario Son Espases
state: Islas Baleares
city: Pamplona
country: Spain
facility: Complejo Hospitalario Navarra (PAMPLONA)
state: Navarra
city: San Cristobal de la Laguna
country: Spain
facility: Hospital Universitario Canarias (TENERIFE)
state: Tenerife
city: Barcelona
country: Spain
facility: Hospital de Mar
city: Madrid
country: Spain
facility: Hospital Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
Study officials:
affiliation: Institut Catalá d'Oncologia (ICO) Badalona
name: Beatriz Cirauqui Cirauqui, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Catalá d'Oncologia (ICO) Girona
name: Jordi Rubió Casadevall, M.D. Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: