Lymphocyte-Sparing And Radio-Immunotherapy in Head and Neck Carcinoma
Trial Parameters
Brief Summary
The aim of this study is to investigate the effect of ATRA (Vesanoid) and the effect of tailored radiotherapy in patients with squamous cell carcinoma of the oropharynx, larynx or hypopharynx.
Eligibility Criteria
Inclusion criteria : I1. Male or female patients aged ≥ 18 years old at time of inform consent signature. I2. Patients with primary head and neck tumour up to, but not crossing the midline, previously untreated with histologically-confirmed squamous cell carcinoma of: * the oropharynx p16-, larynx or hypopharynx : T1/N2a-N2b, T2/N0-N2b, T3/N0-N2b (UICC 8th Ed.), or * the oropharynx p16+ : T1/N1 (multiple nodes), T2-T3/N0-N1 (UICC 8th Ed.). I3. Patients with lymph node staging assessed by an FDG-PET/CT with no contralateral nodal uptake. I4. Patients amenable to treatment with RT or concomitant chemo-radiotherapy as decided by the treating physician as a function of tumor stage, tumor location, performance of the patients. I5. Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1. I6. Adequate hematologic and end-organ function, defined by the following laboratory test results obtained within 7 days prior to randomisation : Hematological (without transfusion within 2 weeks