Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
Conditions
Brief summary
Overall survival (OS) defined as the time between inclusion and death from any cause or the last follow-up contact for patients who are alive.
Detailed description
Progression free survival (PFS) defined as the time between inclusion and first progression according to RECIST 1.1., Incidence and severity of adverse events and serious adverse events during maintenance by the combination of cetuximab and avelumab and until 3 months after the last administration of maintenance (or until the start of a second line treatment if it starts before 3 months) as graded by the NCI Common Terminology Criteria of Adverse Events (NCI-CTCAE) v 5.0.
Interventions
DRUGErbitux 5 mg/mL solution for infusion
DRUGCisplatin 1 mg/ml concentrate for solution for Infusion
DRUGsolution à diluer pour perfusion
Sponsors
Groupe Oncologie Radiotherapie Tete Cou
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall survival (OS) defined as the time between inclusion and death from any cause or the last follow-up contact for patients who are alive. | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression free survival (PFS) defined as the time between inclusion and first progression according to RECIST 1.1., Incidence and severity of adverse events and serious adverse events during maintenance by the combination of cetuximab and avelumab and until 3 months after the last administration of maintenance (or until the start of a second line treatment if it starts before 3 months) as graded by the NCI Common Terminology Criteria of Adverse Events (NCI-CTCAE) v 5.0. | — |
Countries
France
Outcome results
None listed