Actively Recruiting
Compartmentalized Postoperative Radiotherapy in Head and Neck Cancer
Led by Olgun Elicin · Updated on 2026-05-06
50
Participants Needed
3
Research Sites
167 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
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
Official Title
Compartmentalized Postoperative Radiotherapy in Head and Neck Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ECOG performance status between 0 and 2 at registration
- 18 years of age or older
- Baseline toxicity and quality of life assessments completed
- Histologically confirmed squamous cell carcinoma of the oral cavity, oropharynx, larynx, or hypopharynx treated with surgery
- No prior neoadjuvant systemic therapy, or only approved and reimbursed neoadjuvant therapy
- Standard indication for postoperative radiotherapy determined by a multidisciplinary tumor board
- History and physical exam by radiation oncologist within 28 days before registration
- MRI or CT scan of head and neck and chest imaging within 60 days prior to enrollment
- Deemed able to safely undergo standard treatment by multidisciplinary team
- Women of childbearing potential must use contraception and have a negative pregnancy test before inclusion; men must agree not to father a child during and three months after treatment
- Signed informed consent
You will not qualify if you...
- Current or previous other cancers except certain treated skin cancers, cervical carcinoma in situ, low/intermediate risk prostate or breast cancer with no recent progression
- Distant metastases present
- Neoadjuvant therapy given as part of another clinical trial or investigational setting
- Prior radiation overlapping with planned postoperative target volumes
- Residual tumor after surgery (R2 resection)
- Surgery performed more than 6 weeks before registration
- Incomplete pathology data preventing treatment planning
- Expected survival less than 6 months due to other diseases
- Active serious infection requiring intravenous antibiotics
- Illness preventing radiotherapy within 7 days of registration
- Psychological, social, or geographical issues limiting study compliance
- Concurrent participation in other interventional clinical trials without sponsor exemption
AI-Screening
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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.
CONTACT
D
Daniel H Schanne, Dr. med.
CONTACT
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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