An observational study in Squamous Cell Carcinoma of the Head and Neck, sponsored by Grupo Español de Tratamiento de Tumores de Cabeza y Cuello. Completed at 20 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-23.
Sponsored by Grupo Español de Tratamiento de Tumores de Cabeza y Cuello · Observational
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.
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's enrollment of 531 is above the median of 149 across 1,175 observational studies indexed under Carcinoma.
Browse Carcinoma studies →Grupo Español de Tratamiento de Tumores de Cabeza y Cuello is the lead sponsor of 9 studies on the registry; 1 is open to participants now.
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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.
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
Voluntary written consent, if applicable*
Exclusion Criteria:
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.
Drug: Cetuximab · Drug: Paclitaxel
Weekly cetuximab at starting dose, that could be switched to biweekly
Paclitaxel at starting dose of 80 mg/m2
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.
Time frame: Through study completion, average 1 year
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.
Time frame: Through study completion, average 1 year
Overall Response Rate (ORR)
Overall response rate, defined as the proportion of patients with CR or PR as BOR.
Time frame: Through study completion, average 1 year
Disease Control Rate (DCR)
The proportion of patients with CR, PR or SD as BOR.
Time frame: Through study completion, average 1 year
Frequency of Adverse Events (AEs)
Safety will be studied as function of AEs frequency: The number of adverse events classified by type and intensity
Time frame: Through study completion, average 1 year
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.
Time frame: Through study completion, average 1 year
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
Time frame: Through study completion, average 1 year
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.
Time frame: Through study completion, average 1 year
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.
Time frame: Through study completion, average 1 year
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.
Time frame: Through study completion, average 1 year
Plan to share: No
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Grupo Español de Tratamiento de Tumores de Cabeza y Cuello