Actively Recruiting
COMPORT: Personalized Compartmentalized Postoperative Radiotherapy for Head and Neck Squamous Cell Carcinoma
Led by Olgun Elicin · Updated on 2026-05-06
50
Participants Needed
3
Research Sites
12 weeks
Total Duration
On this page
Sponsors
O
Olgun Elicin
Lead Sponsor
C
Clinical Trials Unit, Bern, Switzerland
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating a personalized approach to postoperative radiotherapy for patients with head and neck squamous cell carcinoma (HNSCC). This phase II multicenter trial studies whether a risk-adapted, compartmentalized radiotherapy strategy can safely reduce treatment volumes and side effects without increasing tumor recurrence risk. The study focuses on patients with surgically treated cancers of the oral cavity, oropharynx, larynx, or hypopharynx who have a standard indication for postoperative radiotherapy. Participants will receive pathology- and imaging-guided compartmentalized postoperative radiotherapy (PORT), with or without systemic treatment, where selected anatomical volumes may be intentionally omitted based on a predefined algorithm. This single-arm study aims to assess the safety of this de-escalated treatment, with dose and volume adapted to risk. The study includes accrual over 24 months and follow-up for each patient for 30 months. During the trial, patients will undergo baseline imaging and assessments of toxicity and quality of life. Researchers will monitor recurrence rates in the omitted compartments for 30 months, along with secondary outcomes such as loco-regional control, progression-free survival, overall survival, acute and late toxicity, and patient-reported quality of life. Safety will be reviewed after 20 patients have completed 6 months of follow-up, with the total study duration about 5.5 years.
CONDITIONS
Brief Title
Compartmentalized Postoperative Radiotherapy in Head and Neck Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ECOG performance status 0-2 at registration
- 18 years of age or older
- Baseline toxicity and quality of life assessments completed
- Histopathologically confirmed, surgically treated squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx
- No previous neoadjuvant systemic therapy unless approved and reimbursed or part of routine institutional treatment
- Standard indication for postoperative external beam radiotherapy defined by multidisciplinary tumor board
- History and physical exam by radiation oncologist within 28 days prior to registration
- Required baseline imaging completed within 60 days prior to enrollment
- Multidisciplinary team confirms patient can safely undergo standard treatment
- Women of child-bearing potential use effective contraception and have negative pregnancy test; men agree not to father a child during and shortly after treatment
- Written informed consent obtained
You will not qualify if you...
- Synchronous or previous malignancies except certain low-risk or treated cancers with no active disease
- Presence of distant metastases (c/pM1)
- Neoadjuvant therapy given under clinical trial or investigational framework
- Previous radiation overlapping target volumes that may impact dose or toxicity
- R2 resection of primary tumor or lymph node
- Last oncologic surgery more than 6 weeks prior
- Inadequate pathology reporting preventing risk stratification
- Co-existing disease with expected survival less than 6 months
- Active bacterial or fungal infection requiring IV antibiotics
- Illness preventing postoperative radiotherapy within 7 days
- Psychological, social, or geographical conditions hampering compliance
- Ongoing participation in other interventional clinical trials unless exempted
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for history, physical exam, and baseline assessments
Duration - Typically several weeks following surgery, exact duration depends on individual treatment plan
Participants receive personalized compartmentalized postoperative radiotherapy, with or without systemic treatment, based on pathology and imaging. Some anatomical compartments may be omitted according to a predefined algorithm.
Multiple visits for radiotherapy sessions over several weeks
Duration - Up to 30 months
Participants are monitored for up to 30 months after treatment to assess recurrence, survival, toxicity, and quality of life.
Regular follow-up visits throughout the 30 months
Trial Site Locations
Total: 3 locations
1
University Hospital of Basel
Basel, Switzerland, 4031
Actively Recruiting
2
Inselspital, Bern University Hospital
Bern, Switzerland, 3010
Actively Recruiting
3
University Hospital of Zurich
Zurich, Switzerland, 8091
Actively Recruiting
Research Team
O
Olgun Elicin, Prof. Dr. med.
D
Daniel H Schanne, Dr. med.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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