Phase II Study of Selective Postoperative Radiotherapy Omitting Low-Risk Cervical Nodes for Locally Advanced Head and Neck Squamous Cell Carcinoma

What this Trial Is About

Researchers are studying whether omitting postoperative cervical irradiation for certain patients with locally advanced squamous cell carcinoma of the head and neck who have undergone neck dissection and have low-risk nodal factors is safe and feasible. The study aims to determine if this selective irradiation approach maintains control over regional recurrence while reducing toxicity and preserving immune function and quality of life. The trial compares outcomes to past reports and a retrospective institutional group treated with standard full nodal irradiation. Participants will receive postoperative radiotherapy that excludes low-risk cervical nodal levels based on pathological findings after neck dissection. The radiation is delivered through 30 or 33 sessions of intensity-modulated radiation therapy IMRT or volumetric modulated arc therapy VMAT targeting the primary tumor bed, reaching doses of 60 to 66 Gy. Concomitant cisplatin chemotherapy may be given according to clinical guidelines if high-risk tumor features are present. During the study, participants will attend regular checkups and follow-up visits over 48 months. Researchers will collect blood samples, monitor treatment adherence, assess toxicity at multiple time points up to 24 months, and use quality-of-life questionnaires to evaluate patient well-being. The primary outcome is the regional recurrence rate in non-irradiated cervical areas measured at 24 months, alongside secondary outcomes including progression-free survival, overall survival, toxicity, and immunological markers.

CLEAR (Cervical Lymphatic Exclusion in Adjuvant Radiation)