Proton Re-irradiation in Patients With Recurrent or Second Primary Head and Neck Cancer , a Multicentre Phase II Single Arm Trial

Re-irradiation of head and neck cancer due to relaps or new cancer in the same area may be beneficial, but also poses a risk since the area has been given radiation previously. Proton radiation is a new type of radiotherapy which might result in less damage of healthy tissue around the tumour, but it is still uncertain whether this leads to fewer side effects and improved quality of life. The aim of this study is to collect more knowledge of side-effects, swallowing function, quality of life and disease control after re-irradiation with protons in patients with relaps or second primary head and neck cancer

Inclusion Criteria: * Informed consent received * Age ≥ 18 years * Histological verified squamous cell carcinoma * Candidate for treatment with curative intent * Loco-regional recurrence or new second primary ≥ six months after primary radiotherapy * Medical or surgical inoperable or without free margins ((R1: \< 1mm margin /R2: macroscopic residual tumour) or rpN2-3 or extranodal extension (ENE)) after surgical resection * WHO PS ≤ 2 * Ability to understand and complete the study documents * Complete Response (CR) after previous therapy, except in the case where the recurrence is considered a geometric miss (recurrence center of mass (COM) outside the 95% of prescription dose. Exclusion Criteria: * Distant metastasis * Previous re-irradiation for overlapping second primary or relapse * Severe late effects after primary radiotherapy (osteoradionecrosis, trismus grade 3 or dysphagia grade 3 before recurrence or second primary disease) * Patients with pacemaker/ and/or implanted defibrillators. * Comparative treatment planning showing an overall benefit of photon therapy compared to proton therapy