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

NCT04672772 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 531

Last updated 2022-03-23

No results posted yet for this study

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.

Conditions

  • Squamous Cell Carcinoma of the Head and Neck

Interventions

DRUG

Cetuximab

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

DRUG

Paclitaxel

Paclitaxel at starting dose of 80 mg/m2

Sponsors & Collaborators

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

    collaborator INDUSTRY

  • Grupo Español de Tratamiento de Tumores de Cabeza y Cuello

    lead OTHER

Principal Investigators

  • Beatriz Cirauqui Cirauqui, M.D. Ph.D. · Institut Catalá d'Oncologia (ICO) Badalona

  • Jordi Rubió Casadevall, M.D. Ph.D. · Institut Catalá d'Oncologia (ICO) Girona

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-18
Primary Completion
2022-01-17
Completion
2022-01-17

Countries

  • Spain

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04672772 on ClinicalTrials.gov