Randomized Clinical Trial Comparing Weekly Low-Dose and High-Dose Cisplatin with Radiation for Locally Advanced Head and Neck Cancer

What this Trial Is About

Researchers are evaluating treatment options for patients with locally advanced head and neck squamous cell carcinoma LASCCHN, focusing on comparing different dosing schedules of cisplatin chemotherapy combined with radiation. The study aims to resolve uncertainty about the best cisplatin dosing method to reduce hearing loss and improve quality of life in patients undergoing chemoradiotherapy. This trial also explores genetic factors that may influence the risk of hearing damage from cisplatin treatment. Participants will be randomly assigned to receive either high-dose cisplatin given on days 1, 22, and 43 or a low-dose weekly cisplatin schedule, both administered intravenously alongside radiation therapy. The radiation treatment follows local planning and delivery standards at participating centers. The study includes a prospective, open-label design with 100 patients grouped by tumor p16 status. During the study, participants will undergo assessments including hearing-related quality of life evaluations up to one year after treatment starts. Researchers will monitor hearing loss severity, neuropathy, kidney function, and genetic markers at multiple time points. Quality of life questionnaires and clinical exams will be completed, along with long-term follow-up to assess treatment impact and safety. The total participation duration includes baseline, treatment, and up to one year of post-treatment observation.

Low-Dose Weekly vs High-Dose Cisplatin