Actively Recruiting
Led by University of Leipzig · Updated on 2024-09-20
140
Participants Needed
9
Research Sites
104 weeks
Total Duration
U
University of Leipzig
Lead Sponsor
U
University of Göttingen
Collaborating Sponsor
This trial investigates advanced stage III and IV head and neck squamous cell carcinoma of the larynx or hypopharynx with PD-L1 expression, focusing on patients eligible for total laryngectomy. Researchers are comparing standard treatment involving induction chemotherapy with docetaxel and cisplatin followed by radiation to a similar treatment plus the addition of pembrolizumab, a PD-1 inhibitor. The goal is to evaluate whether adding pembrolizumab improves laryngectomy-free survival and other outcomes. Participants are randomly assigned to one of two groups. The standard group receives one cycle of induction chemotherapy followed by response evaluation; responders get two more cycles and then radiotherapy, while nonresponders undergo total laryngectomy plus selective neck dissection and postoperative radiation or chemoradiation. The experimental group receives the same chemotherapy and radiation schedule plus pembrolizumab given intravenously every three weeks for up to 12 months, regardless of initial response or subsequent treatments. During the study, participants undergo tumor surface shrinkage assessment after the first chemotherapy cycle to guide treatment decisions. Researchers will monitor laryngectomy-free survival over 24 to 48 months, along with swallowing quality assessed by FEES, event-free survival, and overall survival. Safety, functional outcomes, and long-term follow-up are included, with evaluations continuing for up to four years. The total participation duration varies depending on individual response and follow-up.
CONDITIONS
European Larynx Organ Preservation Study (ELOS) [MK-3475-C44]
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 10 weeks
Participants receive an initial cycle of chemotherapy with Docetaxel and Cisplatin followed by an early response evaluation. Responders continue with two additional chemotherapy cycles aiming for larynx organ preservation, while nonresponders proceed to surgery.
3 chemotherapy cycles with visits around weeks 1, 5-7, and 8-10 plus an early response evaluation visit in week 4
Duration - Radiotherapy: about 5.5 weeks; Pembrolizumab: up to 12 months
Participants receive radiotherapy after chemotherapy. Those in the experimental arm also receive pembrolizumab intravenously every 3 weeks for up to 12 months, regardless of response to chemotherapy or surgery.
Radiotherapy visits over 5.5 weeks and pembrolizumab infusions every 3 weeks for up to 17 cycles
Duration - Postoperative care duration varies according to clinical decision
Nonresponders to induction chemotherapy undergo total laryngectomy and selective neck dissection followed by postoperative radiation or chemoradiation as decided by the tumor board.
Approximately 1 hospital stay for surgery plus 6 or more post-operative visits depending on therapy
Duration - 24 to 48 months
Participants are monitored for survival, quality of swallowing, and event-free status for up to 48 months after treatment completion.
Regular follow-up visits during this period according to study schedule
Total: 9 locations
1
Universitätsklinikum Mannheim, Klinik für Hals-Nasen-Ohrenheilkunde Theodor-Kutzer-Ufer 1-3
Mannheim, Baden-Würtemberg, Germany, 68167
Actively Recruiting
2
Universitätsklinikum Ulm / Ulm University Medical Center, Klinik für Hals- Nasen-Ohrenheilkunde und Kopf-Halschirurgie, Frauensteige 12
Ulm, Baden-Würtemberg, Germany, 89075
Actively Recruiting
3
Klinikum rechts der Isar der TU München, Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde, Ismaninger Straße 22
München, Bavaria, Germany, 81675
Not Yet Recruiting
4
Universität Regensburg, Klinik und Poliklinik für Strahlentherapie Franz-Josef-Strauss-Allee 11
Regensburg, Bavaria, Germany, 93053
Actively Recruiting
5
Universitätsklinikum Würzburg, Klinik für Hals-, Nasen-, Ohrenheilkunde, Josef-Schneider-Straße 8
Würzburg, Bavaria, Germany, 97080
Actively Recruiting
6
Klinikum Ernst von Bergmann, Klinik für Hämatologie, Onkologie und Palliativmedizin, Charlottenstr. 72
Potsdam, Brandenburg, Germany, 14467
Not Yet Recruiting
7
Universitätsklinikum Köln, Klinik für Hals-, Nasen-, Ohrenheilkunde, Kerpener Str. 62
Cologne, North Rhine-Westphalia, Germany, 50937
Not Yet Recruiting
8
University of Leipzig, Department für Kopf- und Zahnmedizin, Klinik und Poliklinik für Hals-, Nasen- und Ohrenheilkunde, Liebigstrasse 12
Leipzig, Saxon, Germany, 04103
Actively Recruiting
9
Universitätsklinikum Jena Klinik für Hals-, Nasen- und Ohrenheilkunde, Am Klinikum 1
Jena, Thuringia, Germany
Not Yet Recruiting
A
Andreas Dietz, MD PhD
S
Susanne Wiegand, MD PhD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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