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

NCT ID: NCT04672772

Last Updated: 2022-03-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 531 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-18
• Study Completion Date: 2022-01-17

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.

Conditions

Squamous Cell Carcinoma of the Head and Neck

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Cetuximab

Intervention Type: DRUG

Weekly cetuximab at starting dose, that could be switched to biweekly

Paclitaxel

Intervention Type: DRUG

Paclitaxel at starting dose of 80 mg/m2

Interventions

Cetuximab

Weekly cetuximab at starting dose, that could be switched to biweekly

Intervention Type: DRUG

Paclitaxel

Paclitaxel at starting dose of 80 mg/m2

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

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

INDUSTRY

Sponsor Role: collaborator

Grupo Español de Tratamiento de Tumores de Cabeza y Cuello

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Beatriz Cirauqui Cirauqui, M.D. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Institut Catalá d'Oncologia (ICO) Badalona

Jordi Rubió Casadevall, M.D. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Institut Catalá d'Oncologia (ICO) Girona

Locations

Hospital Universitario Virgen de las Nieves

Granada, Andalusia, Spain

Hospital Regional Universitario de Málaga

Málaga, Andalusia, Spain

Hospital Universitario Virgen de Valme

Seville, Andalusia, Spain

Hospital Universitario Miguel Servet

Zaragoza, Aragon, Spain

Hospital Universitario Son Espases

Palma de Mallorca, Balearic Islands, Spain

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, Spain

Hospital Universitario de Salamanca

Salamanca, Castille and León, Spain

Hospital Virgen de la Salud

Toledo, Castille-La Mancha, Spain

Institut Catalá d'Oncologia (ICO) Badalona

Badalona, Catalonia, Spain

Institut Catalá d'Oncologia (ICO) Girona

Girona, Catalonia, Spain

Hospital Duran i Reynalds (ICO-Hospitalet)

L'Hospitalet de Llobregat, Catalonia, Spain

Centro Oncológico de Galicia

A Coruña, Galicia, Spain

Hospital Universitario Lucus Augusti

Lugo, Galicia, Spain

Complejo Hospitalario Navarra (PAMPLONA)

Pamplona, Navarre, Spain

Hospital Universitario Canarias (TENERIFE)

San Cristóbal de La Laguna, Tenerife, Spain

Hospital Universitario y Politécnico La Fe

Valencia, Valencia, Spain

Hospital de Mar

Barcelona, , Spain

Hospital Universitario Gregorio Marañón

Madrid, , Spain

Hospital Universitario Clínico San Carlos

Madrid, , Spain

Hospital Universitario 12 de Octubre

Madrid, , Spain

Countries

Spain

Other Identifiers

TTC-CET-2020-01

Identifier Type: OTHER

Identifier Source: secondary_id

TTCC-2019-02

Identifier Type: -

Identifier Source: org_study_id