Compartmentalized Postoperative Radiotherapy in Head and Neck Cancer

Exclusion Criteria

• •1. 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).
• •2. Presence of distant metastases c/pM1.
• •3. 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.
• •4. 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.
• •5. R2 resection of the primary tumor or any involved lymph node.
• •6. Last oncologic surgery for the index HNSCC performed more than 6 weeks ago.
• •7. 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)
• •8. Co-existing disease prejudicing survival (expected survival less than 6 months).
• •9. Active bacterial or fungal infection requiring intravenous antibiotics at the time of registration.
• •10. Illness expected to preclude PORT within 7 days of registration.
• •11. 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.
• •12. 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).