Head and Neck CancerPhase 2COMPORTNCT07058805
Compartmentalized Postoperative Radiotherapy in Head and Neck Cancer
A Phase 2 study testing Compartmentalized Postoperative Radiotherapy in people with Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, run by Olgun Elicin at 3 sites in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma, Oral Cavity Squamous Cell Carcinoma
- What is being tested?
- Compartmentalized Postoperative Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 3 sitesSwitzerland
- Study dates
- 15 Jan 2026to Apr 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Previous neoadjuvant systemic therapy (chemotherapy, immunotherapy or combinations, e.g. KEYNOTE-68922) 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).
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- 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.
- Post-menopausal women, or women of child-bearing potential who use or agree to use effective contraception, are not pregnant and agree not to become pregnant during and within 30 days after PORT. A negative pregnancy test before inclusion (within 28 days) into the trial is required for all women with child-bearing potential. Men agree not to father a child during and within three months after PORT.
- Written informed consent, signed by the patient and the investigator.
Who cannot join
- 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.
- Previous neck dissection prior to the diagnosis of the index tumor
- 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.
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- R2 resection of the primary tumor or macroscopic residual disease of 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).
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland3 sites, 3 recruiting
- Recruiting
University Hospital of Basel
Basel, 4031
Marco Radovic, +41 61 265 49 40, marco.radovic@usb.ch
- Recruiting
Inselspital, Bern University Hospital
Bern, 3010
Olgun Elicin, +41 31 632 24 31, olgun.elicin@insel.ch
- Recruiting
University Hospital of Zurich
Zurich, 8091
Panagiotis Balermpas, +41 79 749 33 75, panagiotis.balermpas@usz.ch
About this study
Official title: COMPORT: Compartmentalization in Postoperative Radiotherapy for Head and Neck Squamous Cell Carcinoma - A Phase II Clinical Trial
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.
Read the detailed description
Background and Rationale:
Head and neck squamous cell carcinoma (HNSCC) is commonly treated with surgery followed by radiotherapy, but conventional large-volume irradiation leads to considerable toxicity. Previous studies, including retrospective work by the COMPORT team (Riggenbach et al. 2024), have shown that a compartmentalized, de-intensified radiotherapy approach may reduce morbidity without compromising oncologic outcomes.
Study Objective:
To evaluate the safety of omitting radiotherapy in selected anatomical compartments that would normally be treated based on standard guidelines (Evans et al. 2018/2025), using a pathology-driven stratification algorithm.
Design:
Bayesian, multicenter, single-arm phase II trial with 50 patients. The primary endpoint is the rate of recurrence in omitted (non-irradiated) compartments within 30 months. Secondary endpoints include loco-regional control, progression-free survival, overall survival, CTCAE-based toxicity scoring (TAME), and patient-reported quality of life (EORTC C30 + HN43).
Analysis Strategy:
The primary analysis will estimate the posterior probability that the recurrence rate in omitted (non-irradiated) compartments remains below a predefined threshold of 18%. If this probability exceeds 90%, the de-escalation strategy will be deemed successful. This would support the rationale for a future phase III randomized trial using a more conservative non-inferiority margin. A predefined interim safety analysis will be conducted once 20 patients have completed at least 6 months of follow-up.
Duration:
Accrual over 24 months, each patient followed for 30 months. Total study period: ~5.5 years.
- 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
- Being tested
- Compartmentalized Postoperative Radiotherapy
- 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
- Medical subject headings
- Head and Neck Neoplasms, Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Compartmentalized Postoperative RadiotherapyRadiation
Also called postoperative adjuvant treatment
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Radiation: Compartmentalized Postoperative Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 30 months from first patient enrollment
Secondary outcomes (6)
Loco-regional Control (LRC)
Time to loco-regional failure, including recurrences within irradiated and non-irradiated compartments.
Measured: 30 months
Progression-free Survival (PFS)
Time from registration to disease progression or death from any cause.
Measured: 30 months
Overall Survival (OS)
Time from registration to death from any cause.
Measured: 30 months
Acute and Late Toxicity
Frequency and severity of adverse events using CTCAE v5.0, scored prospectively using the TAME method.
Measured: 30 months
Patient-Reported Global Quality of Life (EORTC QLQ-C30)
The European Organisation for Research and Treatment of Cancer Quality of Life Core Questionnaire-30 (EORTC QLQ-C30) will be used to assess overall and functional quality of life at baseline, post-treatment, and follow-up. The instrument consists of 30 items grouped into multi-item functional scales (Physical, Role, Emotional, Cognitive, Social), symptom scales (e.g., Fatigue, Pain, Nausea/Vomiting), and a global quality of life scale. Each score is linearly transformed to a scale from 0 to 100 according to the official scoring manual. For functional and global health/QoL scales, higher scores represent better functioning or quality of life. For symptom scales, higher scores represent greater symptom burden. The EORTC QLQ-C30 does not generate a total summary score.
Measured: 30 months
Patient-Reported Head and Neck Cancer-specific Quality of Life (EORTC QLQ-HN43)
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Head and Neck Cancer module (EORTC QLQ-HN43) will be used to assess specific symptom domains related to head and neck cancer and its treatment. It consists of 43 items grouped into symptom scales and single items (e.g., speech, swallowing, dry mouth, sticky saliva, pain, body image). Each score is linearly transformed to a scale from 0 to 100. Higher scores indicate greater symptom burden. There is no total score. This module is validated for use in conjunction with the EORTC QLQ-C30 in patients with head and neck cancer.
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start15 Jan 2026
- Primary completionJan 2029 (estimated)
- Study completionApr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Bayesian single-arm phase II design evaluating compartmentalized postoperative radiotherapy in head and neck squamous cell carcinoma.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Olgun Elicin
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Trials Unit, Bern, Switzerland, Fond'action contre le cancer, University Hospital, Zürich, University Hospital, Basel, Switzerland, Kantonsspital Aarau, Oncology Institute of Southern Switzerland, Insel Gruppe AG, University Hospital Bern
- Responsible party
- Sponsor-investigator, Olgun Elicin, Insel Gruppe AG, University Hospital Bern
- Investigators
- Timo Nannen, Study director, Inselspital, Bern University Hospital and University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058805
- Sponsor's protocol ID
- KEK-BE-2025-01420
- Acronym
- COMPORT
- Status last verified
- Apr 2026
- First submitted
- 22 Jun 2025
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data sharing is under consideration but has not yet been finalized. An anonymized individual participant data (IPD) set may be made available upon reasonable request following publication of the primary results and approval by the sponsor and ethics committee.
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPORT: Compartmentalization in Postoperative Radiotherapy for Head and Neck Squamous Cell Carcinoma - A Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT07058805
- Acronym / sponsor ID
- COMPORT / KEK-BE-2025-01420
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Olgun ElicinUniversity, hospital or other
- Collaborators
- Clinical Trials Unit, Bern, Switzerland, Fond'action contre le cancer, University Hospital, Zürich, University Hospital, Basel, Switzerland, Kantonsspital Aarau, Oncology Institute of Southern Switzerland, Insel Gruppe AG, University Hospital Bern
- Study start
- 15 Jan 2026 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Apr 2029 (estimated)
- First posted
- 10 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background and Rationale:
Head and neck squamous cell carcinoma (HNSCC) is commonly treated with surgery followed by radiotherapy, but conventional large-volume irradiation leads to considerable toxicity. Previous studies, including retrospective work by the COMPORT team (Riggenbach et al. 2024), have shown that a compartmentalized, de-intensified radiotherapy approach may reduce morbidity without compromising oncologic outcomes.
Study Objective:
To evaluate the safety of omitting radiotherapy in selected anatomical compartments that would normally be treated based on standard guidelines (Evans et al. 2018/2025), using a pathology-driven stratification algorithm.
Design:
Bayesian, multicenter, single-arm phase II trial with 50 patients. The primary endpoint is the rate of recurrence in omitted (non-irradiated) compartments within 30 months. Secondary endpoints include loco-regional control, progression-free survival, overall survival, CTCAE-based toxicity scoring (TAME), and patient-reported quality of life (EORTC C30 + HN43).
Analysis Strategy:
The primary analysis will estimate the posterior probability that the recurrence rate in omitted (non-irradiated) compartments remains below a predefined threshold of 18%. If this probability exceeds 90%, the de-escalation strategy will be deemed successful. This would support the rationale for a future phase III randomized trial using a more conservative non-inferiority margin. A predefined interim safety analysis will be conducted once 20 patients have completed at least 6 months of follow-up.
Duration:
Accrual over 24 months, each patient followed for 30 months. Total study period: ~5.5 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Bayesian single-arm phase II design evaluating compartmentalized postoperative radiotherapy in head and neck squamous cell carcinoma.
| Arm | Type | Receives |
|---|---|---|
| Compartmentalized postoperative radiotherapy PORT with other without systemic treatment | Experimental | Radiation: Compartmentalized Postoperative RadiotherapySingle-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
- Previous neoadjuvant systemic therapy (chemotherapy, immunotherapy or combinations, e.g. KEYNOTE-68922) 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.
Key exclusion criteria (14 listed)
- 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.
- Previous neck dissection prior to the diagnosis of the index tumor
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Compartmentalized Postoperative RadiotherapyAlso: postoperative adjuvant treatmentPathology- 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. | Radiation | Compartmentalized postoperative radiotherapy PORT with other without systemic treatment |
Primary outcome
Recurrence Rate in Omitted Compartments
Time frame: 30 months from first patient enrollment
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).
6 secondary outcomes
Loco-regional Control (LRC)
Time frame: 30 months
Progression-free Survival (PFS)
Time frame: 30 months
Overall Survival (OS)
Time frame: 30 months
Acute and Late Toxicity
Time frame: 30 months
Patient-Reported Global Quality of Life (EORTC QLQ-C30)
Time frame: 30 months
Patient-Reported Head and Neck Cancer-specific Quality of Life (EORTC QLQ-HN43)
Time frame: 30 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Individual participant dataSharing planned: Undecided. Data sharing is under consideration but has not yet been finalized. An anonymized individual participant data (IPD) set may be made available upon reasonable request following publication of the primary results and approval by the sponsor and ethics committee.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Timo Nannen study director
Inselspital, Bern University Hospital and University of Bern
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Compartmentalized Postoperative Radiotherapy in people with Head and Neck Cancer and Head and Neck Squamous Cell Carcinoma, run by Olgun Elicin at 3 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Olgun Elicin, Prof. Dr. med. (+41 31 632 26 32, Olgun.Elicin@insel.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence Rate in Omitted Compartments (time frame: 30 months from first patient enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2026.