Locally advanced squamous cell carcinoma of the head and neck
Conditions
Brief summary
PFS as assessed by independent review committee (IRC) defined as the time from randomization to the first occurrence of any of the following events: death from any cause, disease progression (PD), primary treatment failure before achieving a complete response (CR) or any radiological or clinical relapse after achieving a CR
Detailed description
OS, main secondary endpoint, defined as the time from date of randomization to the date of death. Patients last known to be alive will be censored at date of last contact., Progression-free survival by investigator assessment., Compliance will be reported: for radiotherapy (tumor dose, number of fractions, duration and major deviations), for xevinapant/placebo, cetuximab (number of cycles, dose, duration, dose intensity and relative dose intensity). Whatever the treatment, treatment interruption, reduction and discontinuation and their reasons will be reported, Occurrence of adverse events (AEs) and treatment-related AEs.
Interventions
Sponsors
Groupe Oncologie Radiotherapie Tete Cou
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PFS as assessed by independent review committee (IRC) defined as the time from randomization to the first occurrence of any of the following events: death from any cause, disease progression (PD), primary treatment failure before achieving a complete response (CR) or any radiological or clinical relapse after achieving a CR | — |
Secondary
| Measure | Time frame |
|---|---|
| OS, main secondary endpoint, defined as the time from date of randomization to the date of death. Patients last known to be alive will be censored at date of last contact., Progression-free survival by investigator assessment., Compliance will be reported: for radiotherapy (tumor dose, number of fractions, duration and major deviations), for xevinapant/placebo, cetuximab (number of cycles, dose, duration, dose intensity and relative dose intensity). Whatever the treatment, treatment interruption, reduction and discontinuation and their reasons will be reported, Occurrence of adverse events (AEs) and treatment-related AEs. | — |
Countries
France
Outcome results
None listed