Hypofractionated Radiotherapy for HNSCC in Elderly Patients

This study aims to conduct a prospective study to evaluate the efficacy and safety of segmented hypofractionated radiotherapy in elderly patients with head and neck squamous cell carcinoma and to explore a radiotherapy fractionation scheme suitable for elderly HNSCC patients in China.

Inclusion criteria

• Age ≥ 65 years;
• Patients with histologically or cytologically confirmed stage II-IVA head and neck squamous cell carcinoma (AJCC 8th edition), including oral cavity, oropharynx, hypopharynx, larynx, and cervical metastatic squamous carcinoma of unknown primary;
• At least one measurable lesion;
• No prior systemic antitumor treatment or locoregional therapy for head and neck squamous cell carcinoma;
• ECOG performance status of 1-3;
• Expected survival time of ≥ 3 months;
• Patients assessed by the physician as unsuitable for surgical treatment and not candidates for radical radiotherapy;
• Functional status of vital organs compatible with daily basic activities (excluding any blood components or cell growth factors within 14 days): adequate bone marrow reserve function: white blood cells (WBC) ≥ 2.0 × 10^9/L, neutrophil count (NEUT) ≥ 1.0 × 10^9/L, platelet count (PLT) ≥ 80 × 10^9/L, hemoglobin (Hb) ≥ 90 g/L;
• Able and willing to comply with the study and follow-up procedures;
• The subject voluntarily agrees to participate in this clinical study and signs the informed consent form, demonstrating good compliance and ability to cooperate with follow-up.

Exclusion criteria

• Previously undergone radiotherapy for head and neck cancer;
• Squamous cell carcinoma of other primary sites in the head and neck, such as paranasal sinuses, nasopharynx, glottic laryngeal cancer, skin, or salivary gland tissues;
• Concurrent other antitumor therapies;
• Neoadjuvant therapy;
• Subjects who have experienced a severe infection within one month before enrollment, including but not limited to infections requiring hospitalization, bacteremia, severe pneumonia, etc.;
• Subjects with any active infection or unexplained fever > 38.5°C occurring during the screening period or before the first dose;
• Presence of severe cardiovascular diseases: Grade II or higher myocardial ischemia or myocardial infarction, poorly controlled arrhythmias (including QTc interval male ≥ 450 ms, female ≥ 470 ms); NYHA Class III-IV heart failure (according to the New York Heart Association classification, see Appendix 3), or echocardiogram indicating left ventricular ejection fraction (LVEF) < 50%;
• History of other malignancies within the past five years (except for completely treated in situ cervical cancer or basal cell carcinoma or squamous cell carcinoma of the skin);
• History of substance abuse involving psychiatric drugs that cannot be discontinued or presence of mental disorders.