Locoregionally recurrent head and neck squamous cell carcinoma (HNSCC)
Conditions
Brief summary
The primary endpoint of the trial is overall survival (OS). OS is defined as the time from the date of randomization to the date of death for any cause.
Detailed description
Progression-free survival (PFS), Locoregional tumor control, Location of locoregional tumor progression (in-field, out-of-field), Distant tumor control, Tumor related death, Response rate according to RECIST 1.1 criteria, Acute and late toxicity according to CTCAE version 5.0, Assessment of the patients tumor symptom burden (questionnaire), Assessment of swallowing function (EAT-10), Assessment of quality of life (EORTC QLQ-C30 and H&N-35)
Interventions
DRUGFLUOROURACIL
DRUGCARBOPLATIN
DRUGPEMBROLIZUMAB
DRUGCISPLATIN
Sponsors
Universitaet Des Saarlandes
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the trial is overall survival (OS). OS is defined as the time from the date of randomization to the date of death for any cause. | — |
Secondary
| Measure | Time frame |
|---|---|
| Progression-free survival (PFS), Locoregional tumor control, Location of locoregional tumor progression (in-field, out-of-field), Distant tumor control, Tumor related death, Response rate according to RECIST 1.1 criteria, Acute and late toxicity according to CTCAE version 5.0, Assessment of the patients tumor symptom burden (questionnaire), Assessment of swallowing function (EAT-10), Assessment of quality of life (EORTC QLQ-C30 and H&N-35) | — |
Countries
Germany
Outcome results
None listed