Status:
COMPLETED
Cetuximab Plus Paclitaxel as First Line for Recurrent and/or Metastatic SCCHN: Real World Data.
Lead Sponsor:
Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
Collaborating Sponsors:
Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
Conditions:
Squamous Cell Carcinoma of the Head and Neck
Eligibility:
All Genders
18+ years
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 h...
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 h...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 18 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 17 2022
Estimated Enrollment :
531 Patients enrolled
Trial Details
Trial ID
NCT04672772
Start Date
December 18 2020
End Date
January 17 2022
Last Update
March 23 2022
Active Locations (20)
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1
Hospital Universitario Virgen de las Nieves
Granada, Andalusia, Spain, 18014
2
Hospital Regional Universitario de Málaga
Málaga, Andalusia, Spain, 29010
3
Hospital Universitario Virgen de Valme
Seville, Andalusia, Spain, 41014
4
Hospital Universitario Miguel Servet
Zaragoza, Aragon, Spain, 50009