Dose De-escalation and Sentinel LN Mapping Driven Radiotherapy of Contralateral Neck in Ipsilateral Node Positive HNSCC
Trial Parameters
Brief Summary
The study involves head and neck squamous cell carcinomas (HNSCC) of the oral cavity, oropharynx, larynx or hypopharynx with positive nodes on only one side of the neck and no distant metastasis treated by primary (chemo)radiotherapy. The elective node irradiation on the contralateral side is not always mandatory and the dose may be too high. In this study, we evaluate two strategies: the impact of sentinel lymph node mapping to tailor the volumes to irradiate and the dose reduction.
Eligibility Criteria
Inclusion criteria 1. Written informed consent given according to ICH/GCP and national/local regulations must be obtained prior to any screening procedures. 2. World Health Organization (WHO) performance status 0-1. 3. Age ≥ 18 years. 4. Patients with a pathologically proven invasive HNSCC, including oral cavity, oropharynx (independently of HPV status), larynx or hypopharynx. 5. Decision by Multidisciplinary Tumor Board of primary treatment with radical radiotherapy with or without concurrent chemotherapy (according to the local guidelines). 6. Baseline imaging of the neck: 1. ≤ 2.5 mm slices CT with iodine injection (independently or during the FDG-PET/CT examination IF acquired in normal diagnostic conditions, i.e. arms along the thorax with diagnostic quality); 2. MRI not mandatory but allowed, performed according to centres guidelines; 3. FDG-PET/CT. 7. Tumor characteristics: 1. cT-classification (8th TNM staging): T1(except T1 of glottis)-T4a (or, for p16+ oropharyngeal tumors cl