Advanced stage III, calculated as CPS ≥ 1, III, is mandatory., IVA, IVB hypopharyngeal squamous cell carcinoma (SCC) curable by total laryngectomy. Note: PD-L1-expression within tumor tissue biopsy, IVB laryngeal or II
Conditions
Brief summary
24-month to 48-month laryngectomy-free survival, the survival of the patient without laryngectomy, in the intent-to-treat population (flexible follow-up of the total cohort until 24 months after randomization of the last patient accrued). Laryngectomy or death from any cause count as event. Patients lost to follow-up will be censored at date of last visit with larynx at place.
Detailed description
24-months to 48-months event-free survival (flexible follow-up), 24-months to 48-months overall survival (flexible follow-up), Quality of swallowing (QoS) assessed by FEES at time of randomization, 6 months and 24 months after IC-1
Interventions
DRUGCISPLATIN
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGDEXAMETHASONE
DRUGDOCETAXEL
Sponsors
University of Leipzig
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 24-month to 48-month laryngectomy-free survival, the survival of the patient without laryngectomy, in the intent-to-treat population (flexible follow-up of the total cohort until 24 months after randomization of the last patient accrued). Laryngectomy or death from any cause count as event. Patients lost to follow-up will be censored at date of last visit with larynx at place. | — |
Secondary
| Measure | Time frame |
|---|---|
| 24-months to 48-months event-free survival (flexible follow-up), 24-months to 48-months overall survival (flexible follow-up), Quality of swallowing (QoS) assessed by FEES at time of randomization, 6 months and 24 months after IC-1 | — |
Countries
Germany
Outcome results
None listed