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

Squamous Cell Carcinoma of the Head and Neck Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04672772
• Other study ID #: TTCC-2019-02
• Secondary ID: TTC-CET-2020-01
• Status: Completed
• Start date: December 18, 2020
• Est. completion date: January 17, 2022

Study information

• Verified date: March 2022
• Source: Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 531
• Est. completion date: January 17, 2022
• Est. primary completion date: January 17, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Squamous Cell Carcinoma of Head and Neck
• Squamous Cell Carcinoma of the Head and Neck

Intervention

Drug:
• Cetuximab
Weekly cetuximab at starting dose, that could be switched to biweekly
• Paclitaxel
Paclitaxel at starting dose of 80 mg/m2

Locations

Country	Name	City	State
Spain	Centro Oncológico de Galicia	A Coruña	Galicia
Spain	Institut Catalá d'Oncologia (ICO) Badalona	Badalona	Cataluña
Spain	Hospital de Mar	Barcelona
Spain	Institut Catalá d'Oncologia (ICO) Girona	Girona	Cataluña
Spain	Hospital Universitario Virgen de las Nieves	Granada	Andalucia
Spain	Hospital Duran i Reynalds (ICO-Hospitalet)	Hospitalet de Llobregat	Cataluña
Spain	Hospital Universitario Lucus Augusti	Lugo	Galicia
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Clínico San Carlos	Madrid
Spain	Hospital Universitario Gregorio Marañón	Madrid
Spain	Hospital Regional Universitario de Málaga	Málaga	Andalucia
Spain	Hospital Universitario Son Espases	Palma De Mallorca	Islas Baleares
Spain	Complejo Hospitalario Navarra (PAMPLONA)	Pamplona	Navarra
Spain	Hospital Universitario de Salamanca	Salamanca	Castilla Y Leon
Spain	Hospital Universitario Canarias (TENERIFE)	San Cristobal de la Laguna	Tenerife
Spain	Hospital Universitario Marques de Valdecilla	Santander	Cantabria
Spain	Hospital Universitario Virgen de Valme	Sevilla	Andalucia
Spain	Hospital Virgen de la Salud	Toledo	Castilla La Mancha
Spain	Hospital Universitario y Politécnico La Fe	Valencia	Comunitat Valenciana
Spain	Hospital Universitario Miguel Servet	Zaragoza	Aragon

Sponsors (2)

Lead Sponsor	Collaborator
Grupo Español de Tratamiento de Tumores de Cabeza y Cuello	Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival (PFS)	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
Secondary	Best Overall Response (BOR)	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
Secondary	Overall Response Rate (ORR)	Overall response rate, defined as the proportion of patients with CR or PR as BOR.	Through study completion, average 1 year
Secondary	Disease Control Rate (DCR)	The proportion of patients with CR, PR or SD as BOR.	Through study completion, average 1 year
Secondary	Frequency of Adverse Events (AEs)	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
Secondary	Overall survival (OS)	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
Secondary	Relative dose intensity (RDI)	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
Secondary	Dose-related and compliance data	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
Secondary	Duration of Response (DOR)	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
Secondary	Proportion of long disease-free survivors	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