Compartmentalized Postoperative Radiotherapy in Head and Neck Cancer

NCT07058805 | Recruiting Phase 2

• 1 other identifier: KEK-BE-2025-01420
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Head and Neck Cancer; Head and Neck Squamous Cell Carcinoma; Oral Cavity Squamous Cell Carcinoma; Oropharyngeal Squamous Cell Carcinoma; Laryngeal Squamous Cell Carcinoma; Hypopharyngeal Squamous Cell Carcinoma

Keywords

Head and Neck Cancer; radiotherapy; Postoperative Radiotherapy; De-escalation; Compartmentalization; Phase II; Quality of life; Bayesian Analysis; TAME; EORTC QLQ-C30; EORTC QLQ-HN43; adjuvant treatment

Outcome Measures

Primary Outcomes (1)

• 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).

  30 months from first patient enrollment

Secondary Outcomes (6)

• Loco-regional Control (LRC)

  30 months

• Progression-free Survival (PFS)

  30 months

• Overall Survival (OS)

  30 months

• Acute and Late Toxicity

  30 months

• Patient-Reported Global Quality of Life (EORTC QLQ-C30)

  30 months

Study Arms (1)

Compartmentalized postoperative radiotherapy PORT with other without systemic treatment

EXPERIMENTAL

Single-arm study evaluating personalized, pathology- and imaging-guided compartmentalized postoperative radiotherapy (PORT), with or without systemic treatment, in patients with head and neck squamous cell carcinoma. PORT itself or selected target volumes may be omitted based on a predefined algorithm.

Radiation: Compartmentalized Postoperative Radiotherapy

Interventions

Compartmentalized Postoperative Radiotherapy RADIATION

Pathology- 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.

Also known as: postoperative adjuvant treatment

Compartmentalized postoperative radiotherapy PORT with other without systemic treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 EORTC C30 and HN43 questionnaires.
• Histopathologically confirmed, surgically treated squamous cell carcinoma of the oral cavity, oropharynx, larynx or hypopharynx
• No previous neoadjuvant systemic therapy or previous neoadjuvant systemic therapy (chemotherapy, immunotherapy or combinations) is permitted only if its neoadjuvant use for locally advanced HNSCC is approved by Swissmedic and routinely reimbursed at the time it was administered or if it was administered as part of routine institutional treatment decisions, outside of a clinical trial or other investigational framework.
• Standard indication for PORT via external beam radiotherapy (with or without concomitant systemic treatment) defined by a multidisciplinary head and neck tumor board (MDT).
• History and physical examination by treating radiation oncologist within 28 days prior to registration.
• MRI of the head and neck (or computerized tomography as substitute) with i.v. contrast, if not contraindicated. CT of the chest with i.v. contrast, if not contraindicated. 18FDG-PET/CT can be used instead of CT of the chest. The baseline imaging examinations include the preoperative diagnostic phase and do not have to be repeated if performed within 60 days prior to the enrollment.
• The multidisciplinary team (MDT) must determine that the patient can safely undergo the standard treatment, which may include PORT with or without additional systemic treatment.
• Written informed consent, signed by the patient and the investigator.

You may not qualify if:

• 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.
• 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.
• Previous radiation dose applied to the anatomical sites overlapping with the standard PORT target volumes which may have a potential impact on the delivered dose and/or toxicity profile of the standard PORT.
• R2 resection of the primary tumor or any involved lymph node.
• Last oncologic surgery for the index HNSCC performed more than 6 weeks ago.
• Inadequate reporting of the pathology not conformal with COMPORT algorithm and no possibility of an adequate post-hoc acquisition of the necessary information (see the section 8)
• Co-existing disease prejudicing survival (expected survival less than 6 months).
• Active bacterial or fungal infection requiring intravenous antibiotics at the time of registration.
• Illness expected to preclude PORT within 7 days of registration.
• Presence of any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the patient before registration in the trial.
• Ongoing participation in another interventional clinical trial which are not exempted by the sponsor. Exceptions may apply depending on the trial methodology (Please contact sponsor for clarification).

Sponsors & Collaborators

• Olgun Elicin: lead
• Clinical Trials Unit, Bern, Switzerland: collaborator
• Fond'action contre le cancer: collaborator
• University Hospital, Basel, Switzerland: collaborator
• Kantonsspital Aarau: collaborator
• Oncology Institute of Southern Switzerland: collaborator
• University Hospital, Zürich: collaborator
• Insel Gruppe AG, University Hospital Bern: collaborator

Study Sites (3)

University Hospital of Basel

Basel, 4031, Switzerland

RECRUITING

Inselspital, Bern University Hospital

Bern, 3010, Switzerland

RECRUITING

University Hospital of Zurich

Zurich, 8091, Switzerland

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Officials

• Timo Nannen

  Inselspital, Bern University Hospital and University of Bern

  STUDY DIRECTOR

Central Study Contacts

Olgun Elicin, Prof. Dr. med.

CONTACT

+41 31 632 26 32; Olgun.Elicin@insel.ch

Daniel H Schanne, Dr. med.

CONTACT

+41 31 632 26 32; daniel.schanne@insel.ch

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Prof. Dr. med.

Model Details: Bayesian single-arm phase II design evaluating compartmentalized postoperative radiotherapy in head and neck squamous cell carcinoma.

Study Record Dates

• First Submitted: June 22, 2025
• First Posted: July 10, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: May 6, 2026

Record last verified: 2026-04

Locations

CH (3)