Phase III Trial Comparing Standard and Tailored Radiotherapy With or Without All-trans Retinoic Acid ATRA in Patients With Lateralized Squamous Cell Carcinoma of the Oropharynx, Larynx, and Hypopharynx

What this Trial Is About

Researchers are studying patients with squamous cell carcinoma of the oropharynx, larynx, or hypopharynx to evaluate the effects of all-trans retinoic acid ATRA, Vesanoid and tailored radiotherapy. This phase III trial aims to see if these treatments reduce severe lymphopenia and immune aging, potentially improving event-free survival at two years compared to standard radiotherapy alone. The study targets patients with lateralized tumors who have not received prior treatment for this cancer. Participants are randomly assigned to one of four groups standard radiotherapy with follow-up tailored radiotherapy combined with ATRA standard radiotherapy combined with ATRA or tailored radiotherapy with follow-up. Radiotherapy lasts 6 to 8 weeks, delivered as standard or tailored doses, often alongside standard chemotherapy with cisplatin or cetuximab. ATRA is taken orally before and after radiotherapy in specified cycles for assigned groups. After treatment, patients are followed for disease progression, survival, or withdrawal. During the study, patients undergo regular assessments including event-free survival evaluations at multiple intervals up to two years, monitoring for relapse, metastasis, survival, adverse events, and quality of life using several questionnaires. Immunomonitoring is performed at key points during treatment. Researchers also analyze health economics and lymph node status. Safety and patient well-being are closely tracked throughout the study duration, which may last until 2029 or until specified endpoints occur.

Lymphocyte-Sparing And Radio-Immunotherapy in Head and Neck Carcinoma