Hypofractionated Radiotherapy in Older Adults With Head and Neck Squamous Cell Carcinoma

Standard radiotherapy for head and neck squamous cell carcinoma typically requires daily treatments over 6 to 7 weeks. For older adults, these prolonged treatment schedules can cause substantial physical fatigue, travel burden, and treatment interruptions. Hypofractionated radiotherapy delivers higher doses of radiation per session over a shorter total treatment time (approximately 3 weeks), potentially limiting tumor cell regrowth, easing logistical demands on patients, and improving completion rates. The purpose of this randomized controlled trial is to evaluate the clinical effectiveness, safety, and toxicity of hypofractionated radiotherapy compared with standard normofractionated radiotherapy in older adults with non-metastatic head and neck squamous cell carcinoma. Eligible participants aged 65 years and older will be randomly assigned in a 1:1 ratio to receive either: * Hypofractionated Radiotherapy (Intervention): External beam radiotherapy delivered via image-guided intensity-modulated techniques (IMRT/VMAT) once daily over approximately 3 weeks (45 Gy in 15 fractions for definitive therapy, or 40.5 Gy in 15 fractions for postoperative/adjuvant therapy). * Standard Normofractionated Radiotherapy (Comparator): External beam radiotherapy delivered once daily using conventional fractionation schedules over approximately 6 to 7 weeks according to institutional clinical standards. Participants will be monitored weekly during radiation treatment and followed for up to 1 year post-treatment. The primary outcome is locoregional control, with secondary outcomes assessing overall survival, disease-free survival, acute and late toxicities graded by CTCAE version 6.0, and health-related quality of life.

Sex

All

Minimum age

65 Years

Inclusion Criteria:

* Histologically confirmed squamous cell carcinoma of the head and neck.
* Age ≥ 65 years.
* Non-metastatic disease (M0).
* Early-stage or locally advanced disease considered suitable for definitive or postoperative radiotherapy.
* Eastern Cooperative Oncology Group (ECOG) performance status 0 to 2.
* Adequate baseline organ function to safely undergo radiotherapy (including adequate hematological, renal, and hepatic function according to institutional criteria).
* No prior radiation therapy delivered to the head and neck region.
* Ability to understand the study procedures and provide written informed consent.

Exclusion Criteria:

* Presence of distant metastases (M1) at enrollment.
* ECOG performance status \> 2.
* Severe uncontrolled comorbidities that make radiotherapy unsafe.
* Inability to comply with treatment planning, immobilization, or protocol follow-up requirements.
* Refusal or inability to provide written informed consent.