This Protocol Focuses on the Factors That Influence Survival, the Development of Complications and the Quality of Life Based on the Treatment Received in the Group of Patients Suffering From Malignant Lesions of the Head and Neck

San Donato Group (GSD)

Status

Begins enrollment in 2 months

Conditions

Head and Neck Cancer

Treatments

Procedure: treatment received in the group of patients suffering from malignant lesions of the head and neck.

Study type

Observational

Funder types

Other

Identifiers

NCT07066878

RETRO-HN

Details and patient eligibility

About

This protocol focuses on a retrospective, single-center analysis, analyzing the factors that influence survival as the main objective, and secondarily the development of complications and the quality of life based on the treatment received in the group of patients suffering from malignant lesions of the head and neck.

Full description

Head and neck cancers (HNCs) comprise a heterogeneous group of malignancies arising from the mucosal epithelium of the upper aerodigestive tract, including the oral cavity, pharynx (nasopharynx, oropharynx, and hypopharynx), and larynx. These tumors are predominantly squamous cell carcinomas (HNSCC), although salivary gland malignancies and other histologic subtypes such as neuroendocrine tumors or sarcomas are also included in this anatomical classification. Globally, HNCs account for nearly 900,000 new cases and over 400,000 deaths annually, representing a significant burden in both high- and low-income countries.

Over the past decades, improvements in diagnostic imaging (e.g., PET/CT, MRI), surgical techniques (including transoral robotic surgery [TORS] and transoral laser microsurgery [TLM]), radiotherapy modalities (e.g., intensity-modulated radiotherapy [IMRT]), and systemic therapies (platinum-based chemotherapy, targeted agents such as cetuximab, and, more recently, immune checkpoint inhibitors like nivolumab and pembrolizumab) have reshaped the therapeutic landscape. Nevertheless, survival outcomes remain highly variable and largely dependent on tumor site, T and N classification, extranodal extension (ENE), perineural and lymphovascular invasion, margin status, HPV status (particularly in oropharyngeal carcinomas), and patient-related factors such as age, performance status, and comorbidities.

For early-stage tumors (Stage I-II), single-modality treatment-typically surgery or radiotherapy-achieves excellent oncologic outcomes with 5-year overall survival (OS) rates ranging from 70% to 90%. In contrast, patients with locally advanced disease (Stage III-IVB), particularly with hypopharyngeal or advanced laryngeal tumors, face significantly worse prognoses, with 5-year OS rates often below 40%, despite aggressive multimodality treatment. A notable exception is HPV-positive oropharyngeal squamous cell carcinoma (OPSCC), which exhibits favorable biology and enhanced responsiveness to chemoradiation, leading to OS rates exceeding 80-90%, even in advanced stages.

Treatment planning must balance oncologic control with functional preservation. While surgical resection (with or without microvascular reconstruction) remains a mainstay for many subsites, organ-preservation protocols based on concurrent chemoradiotherapy are often preferred for tumors of the oropharynx, hypopharynx, and larynx, particularly in functionally critical areas. However, definitive chemoradiation is associated with substantial acute and late toxicities, including mucositis, dysphagia, xerostomia, aspiration, and long-term dependence on feeding tubes or tracheostomy, which may severely impact health-related quality of life (HRQoL).

In this context, robust comparative analyses of different treatment modalities-taking into account tumor subsite, stage, treatment-related morbidity, complications (e.g., graded by the Clavien-Dindo classification), and validated patient-reported outcome measures such as the EORTC QLQ-H&N35 and the FACT-H&N-are critical for guiding evidence-based, patient-centered care. Understanding the oncologic efficacy, complication profile, and quality of life outcomes across treatment strategies is essential to inform multidisciplinary decision-making and optimize long-term survivorship.

Enrollment

400 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participant is willing and able to provide informed consent for study participation
Age 18 years or older
Histological diagnosis of head and neck cancer (any site, any histology)
Treatment (surgical and/or radiotherapy and/or medical) received at San Raffaele Hospital between January 2014 and January 2024
Consent for use of personal data for scientific purposes

Exclusion criteria

Age under 18 years
No histological diagnosis of head and neck cancer
Treatment not performed at San Raffaele Hospital (surgical and/or radiotherapy and/or medical)
Lack of signed consent for use of personal data for scientific purposes
Severe comorbidities interfering with study participation or treatment protocols
Inability to understand or provide informed consent due to cognitive or psychiatric disorders
Concurrent participation in another clinical trial that may interfere with study outcomes