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New treatment option for Head and Neck Cancer
Official title Compartmentalized Postoperative Radiotherapy in Head and Neck Cancer
ClinicalTrials.gov ID: NCT07058805
What this study is testing
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 24 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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...
You likely can't join if
- Synchronous or previous malignancies. Exceptions are curatively treated basal cell carcinoma or SCC of the skin, or in situ carcinoma of the cervix...
- 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...
- Previous radiation dose applied to the anatomical sites overlapping with the standard PORT target volumes which may have a potential impact on the...
- R2 resection of the primary tumor or any involved lymph node.
- Last oncologic surgery for the index HNSCC performed more than 6 weeks ago.
See the full eligibility criteria
- 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...
- 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...
- 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...
- Written informed consent, signed by the patient and the investigator.
- 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...
- 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...
- Ongoing participation in another treatment clinical trial which are not exempted by the sponsor. Exceptions may apply depending on the trial methodology (Please contact sponsor for clarification).
The study team makes the final eligibility decision.
Where it's taking place
- Basel, Switzerland
- Bern, Switzerland
- Zurich, Switzerland
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Basel, Switzerland; Bern, Switzerland; Zurich, Switzerland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.