Squamous Cell Carcinoma of the Head and NeckNCT04672772
Cetuximab Plus Paclitaxel as First Line for Recurrent and/or Metastatic SCCHN: Real World Data.
An observational study of Squamous Cell Carcinoma of the Head and Neck, run by Grupo Español de Tratamiento de Tumores de Cabeza y Cuello at 20 sites in Spain.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Squamous Cell Carcinoma of the Head and Neck
- What is being tested?
- Cetuximab and Paclitaxel
- How many people
- 531 participants
- Where
- 20 sitesSpain
- Study dates
- 18 Dec 2020to 17 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
20 sites in 1 country.
20 sites in 1 country
Spain20 sites
Centro Oncológico de Galicia
A Coruña, Galicia, 15009
Institut Catalá d'Oncologia (ICO) Badalona
Badalona, Catalonia, 08916
Hospital de Mar
Barcelona, 08003
Institut Catalá d'Oncologia (ICO) Girona
Girona, Catalonia, 17007
Hospital Universitario Virgen de las Nieves
Granada, Andalusia, 18014
Hospital Duran i Reynalds (ICO-Hospitalet)
L'Hospitalet de Llobregat, Catalonia, 08908
Hospital Universitario Lucus Augusti
Lugo, Galicia, 27003
Hospital Universitario Gregorio Marañón
Madrid, 28007
Hospital Universitario Clínico San Carlos
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Regional Universitario de Málaga
Málaga, Andalusia, 29010
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, 07120
Complejo Hospitalario Navarra (PAMPLONA)
Pamplona, Navarre, 31008
Hospital Universitario de Salamanca
Salamanca, Castille and León, 37007
Hospital Universitario Canarias (TENERIFE)
San Cristóbal de La Laguna, Tenerife, 38320
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008
Hospital Universitario Virgen de Valme
Seville, Andalusia, 41014
Hospital Virgen de la Salud
Toledo, Castille-La Mancha, 45004
Hospital Universitario y Politécnico La Fe
Valencia, Valencia, 46026
Hospital Universitario Miguel Servet
Zaragoza, Aragon, 50009
About this study
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.
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.
Read the 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 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.
- Being tested
- Cetuximab, Paclitaxel
- Keywords
- Cetuximab, Paclitaxel, recurrent and/or metastatic, retrospective observational study, Squamous Cell Carcinoma of Head and Neck
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CetuximabDrug
Weekly cetuximab at starting dose, that could be switched to biweekly
PaclitaxelDrug
Paclitaxel at starting dose of 80 mg/m2
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Cetuximab; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, average 1 year
Secondary outcomes (9)
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.
Measured: 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.
Measured: Through study completion, average 1 year
Disease Control Rate (DCR)
The proportion of patients with CR, PR or SD as BOR.
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, average 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start18 Dec 2020
- Primary completion17 Jan 2022
- Study completion17 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of the Head and NeckStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 531 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grupo Español de Tratamiento de Tumores de Cabeza y Cuello
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- Responsible party
- Sponsor
- Investigators
- Beatriz Cirauqui Cirauqui, M.D. Ph.D., Principal investigator, Institut Catalá d'Oncologia (ICO) BadalonaJordi Rubió Casadevall, M.D. Ph.D., Principal investigator, Institut Catalá d'Oncologia (ICO) Girona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04672772
- Sponsor's protocol ID
- TTCC-2019-02
- Other IDs
- TTC-CET-2020-01
- Status last verified
- Mar 2022
- First submitted
- 11 Dec 2020
- Last updated
- 23 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04672772
- Acronym / sponsor ID
- TTCC-2019-02
- Keywords
- Cetuximab, Paclitaxel, recurrent and/or metastatic, retrospective observational study, Squamous Cell Carcinoma of Head and Neck
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 531 participants (actual)
- Lead sponsor
- Grupo Español de Tratamiento de Tumores de Cabeza y CuelloUniversity, hospital or other
- Collaborators
- Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany
- Study start
- 18 Dec 2020 (actual)
- Primary completion
- 17 Jan 2022 (actual)
- Study completion
- 17 Jan 2022 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Recurrent and/or metastatic SCCHN | – | Drug: Cetuximab, Drug: PaclitaxelPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CetuximabWeekly cetuximab at starting dose, that could be switched to biweekly | Drug | Recurrent and/or metastatic SCCHN |
| PaclitaxelPaclitaxel at starting dose of 80 mg/m2 | Drug | Recurrent and/or metastatic SCCHN |
Primary outcome
Progression-free survival (PFS)
Time frame: Through study completion, average 1 year
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.
9 secondary outcomes
Best Overall Response (BOR)
Time frame: Through study completion, average 1 year
Overall Response Rate (ORR)
Time frame: Through study completion, average 1 year
Disease Control Rate (DCR)
Time frame: Through study completion, average 1 year
Frequency of Adverse Events (AEs)
Time frame: Through study completion, average 1 year
Overall survival (OS)
Time frame: Through study completion, average 1 year
Relative dose intensity (RDI)
Time frame: Through study completion, average 1 year
Dose-related and compliance data
Time frame: Through study completion, average 1 year
Duration of Response (DOR)
Time frame: Through study completion, average 1 year
Proportion of long disease-free survivors
Time frame: Through study completion, average 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Beatriz Cirauqui Cirauqui, M.D. Ph.D. principal investigator
Institut Catalá d'Oncologia (ICO) Badalona
Jordi Rubió Casadevall, M.D. Ph.D. principal investigator
Institut Catalá d'Oncologia (ICO) Girona
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Squamous Cell Carcinoma of the Head and Neck, run by Grupo Español de Tratamiento de Tumores de Cabeza y Cuello at 20 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 20 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free survival (PFS) (time frame: Through study completion, average 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2022.