COMPORT is a multicenter phase II clinical trial evaluating a personalized approach to postoperative radiotherapy in patients with head and neck squamous cell carcinoma (HNSCC). The study investigates whether a risk-adapted, compartmentalized radiotherapy strategy can safely reduce the treatment volume, and thus the side effects, without increasing the risk of tumor recurrence. Eligible patients are those with surgically treated cancers of the oral cavity, oropharynx, larynx, or hypopharynx who have a standard indication for postoperative radiotherapy. The primary outcome is the rate of recurrence in anatomical compartments that would normally be irradiated but are intentionally omitted in this study. COMPORT aims to generate high-level evidence to support a more personalized and less toxic standard of care in postoperative head and neck cancer management.
ECOG performance status 0-2 at the time of registration
≥18 years of age
Baseline assessments and documentation of toxicity using CTCAE v.5 and QoL using MDADI, EORTC C30 and HN43 questionnaires.
Histopathologically confirmed, surgically treated squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx
Synchronous or previous malignancies. Exceptions are curatively treated basal cell carcinoma or SCC of the skin, or in situ carcinoma of the cervix uteri, low- or intermediate- risk prostate cancer, or breast with a progression-free follow-up time of at least 3 years without any remaining disease burden, or other previous malignancy with a progression-free interval of at least 5 years without any remaining active/progressive disease burden regardless whether the treatment is completed or ongoing as a maintenance treatment (e.g. androgen deprivation therapy for prostate cancer).
Presence of distant metastases c/pM1.
Recurrent HNSCC
Neoadjuvant systemic therapy administered under a clinical trial protocol or as part of any structured investigational framework not considered standard institutional practice at the time of administration.
Single group
Compartmentalized Postoperative Radiotherapy
RadiationPathology- and imaging-guided compartmentalized postoperative radiotherapy (PORT), with or without concurrent systemic treatment. Based on a predefined algorithm, PORT or specific anatomical volumes may be omitted. Dose prescription and volumes are risk-adapted.
Recurrence Rate in Omitted Compartments
Occurrence of loco-regional recurrence within compartments intentionally omitted from postoperative radiotherapy based on the compartmentalization algorithm compared to the international guidelines (Evans et al. 2018 and 2025).
Loco-regional Control (LRC)
Time to loco-regional failure, including recurrences within irradiated and non-irradiated compartments.
Progression-free Survival (PFS)
Time from registration to disease progression or death from any cause.
Overall Survival (OS)
Time from registration to death from any cause.
Acute and Late Toxicity
Frequency and severity of adverse events using CTCAE v5.0, scored prospectively using the TAME method.
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Olgun Elicin
Lead sponsor
Insel Gruppe AG, University Hospital Bern
Sponsor institution
Clinical Trials Unit, Bern, Switzerland
Collaborator
Fond'action contre le cancer
Collaborator
University Hospital, Zürich
Collaborator
University Hospital, Basel, Switzerland
Collaborator
Kantonsspital Aarau
Collaborator
Oncology Institute of Southern Switzerland
Collaborator
Insel Gruppe AG, University Hospital Bern
Collaborator
