Cetuximab Plus Paclitaxel as First Line for Recurrent and/or Metastatic SCCHN: Real World Data.
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.
2 other identifiers
observational
531
1 country
20
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2020
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 11, 2020
CompletedFirst Posted
Study publicly available on registry
December 17, 2020
CompletedStudy Start
First participant enrolled
December 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 17, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 17, 2022
CompletedMarch 23, 2022
March 1, 2022
1.1 years
December 11, 2020
March 22, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
Best Overall Response (BOR)
Through study completion, average 1 year
Overall Response Rate (ORR)
Through study completion, average 1 year
Disease Control Rate (DCR)
Through study completion, average 1 year
Frequency of Adverse Events (AEs)
Through study completion, average 1 year
Overall survival (OS)
Through study completion, average 1 year
- +4 more secondary outcomes
Study Arms (1)
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.
Interventions
Weekly cetuximab at starting dose, that could be switched to biweekly
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (20)
Hospital Universitario Virgen de las Nieves
Granada, Andalusia, 18014, Spain
Hospital Regional Universitario de Málaga
Málaga, Andalusia, 29010, Spain
Hospital Universitario Virgen de Valme
Seville, Andalusia, 41014, Spain
Hospital Universitario Miguel Servet
Zaragoza, Aragon, 50009, Spain
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, 07120, Spain
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital Universitario de Salamanca
Salamanca, Castille and León, 37007, Spain
Hospital Virgen de la Salud
Toledo, Castille-La Mancha, 45004, Spain
Institut Catalá d'Oncologia (ICO) Badalona
Badalona, Catalonia, 08916, Spain
Institut Catalá d'Oncologia (ICO) Girona
Girona, Catalonia, 17007, Spain
Hospital Duran i Reynalds (ICO-Hospitalet)
L'Hospitalet de Llobregat, Catalonia, 08908, Spain
Centro Oncológico de Galicia
A Coruña, Galicia, 15009, Spain
Hospital Universitario Lucus Augusti
Lugo, Galicia, 27003, Spain
Complejo Hospitalario Navarra (PAMPLONA)
Pamplona, Navarre, 31008, Spain
Hospital Universitario Canarias (TENERIFE)
San Cristóbal de La Laguna, Tenerife, 38320, Spain
Hospital Universitario y Politécnico La Fe
Valencia, Valencia, 46026, Spain
Hospital de Mar
Barcelona, 08003, Spain
Hospital Universitario Gregorio Marañón
Madrid, 28007, Spain
Hospital Universitario Clínico San Carlos
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Beatriz Cirauqui Cirauqui, M.D. Ph.D.
Institut Catalá d'Oncologia (ICO) Badalona
- PRINCIPAL INVESTIGATOR
Jordi Rubió Casadevall, M.D. Ph.D.
Institut Catalá d'Oncologia (ICO) Girona
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2020
First Posted
December 17, 2020
Study Start
December 18, 2020
Primary Completion
January 17, 2022
Study Completion
January 17, 2022
Last Updated
March 23, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share