Phase IIIII Study Comparing Shorter Hypo-fractionated Radiation to Conventional Radiation After Surgery for Head and Neck Squamous Cell Carcinoma

What this Trial Is About

Researchers are evaluating a shorter, hypo-fractionated radiotherapy schedule compared to the conventional longer course for patients with squamous cell carcinoma of the head and neck following surgery. This study aims to test if reducing the number of radiation fractions by half can control cancer growth as well as the standard treatment. The trial addresses the need for more convenient, resource-saving treatment options, especially valuable in settings with limited radiotherapy availability. The study compares two radiation therapy schedules given after surgery the standard regimen delivering 60 Gy over 30 fractions in 6 weeks, and a hypo-fractionated regimen delivering 4 Gy over 15 fractions in 3 weeks. Both treatments are given five days per week. Advances in radiation delivery techniques allow better targeting of tumors while protecting nearby organs, making hypo-fractionation a feasible option. This approach also aligns with practices in other cancers where shorter radiation courses have shown similar outcomes. Participants will receive their assigned radiotherapy schedule and be followed for up to two years. Researchers will monitor cancer control in the treated area, swallowing function, disease-free survival, overall survival, quality of life, and both short-term and long-term side effects using various toxicity scales. The study includes detailed assessments and long-term follow-up to evaluate the safety and effectiveness of the hypo-fractionated radiation compared to the conventional schedule.

Trial Evaluating Hypo-fractionated Accelerated Versus Conventional Fractionated Adjuvant RT in Head & Neck Malignancies