Predicting Toxicity in Elderly Patients With Head and Neck Cancer (PREtoxEL)

European Institute of Oncology

Status: Enrolling

Conditions: Head and Neck Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT06344208

IEO 1647

Details and patient eligibility

About

Predicting toxicity in elderly patients with head and neck cancer:

validating a disease-oriented toxicity predictive tool and integrating it with avail-able screening tools for better outcomes.

Full description

We aim to analyze clinical and biochemical variables to prospectively create and validate an independ-ent predictive score to identify the probability of G3-5 toxicity in HNC elderly patients candidated to a curative treatment with radiation treatment +/- systemic treatment.

Enrollment: 3 estimated patients

Sex: All

Ages: 70 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged ≥ 70 years
• Histological diagnosis of squamous cell or undifferentiated HNC in stage III-IV AJCC ed VIII (si-nonasal, nasopharynx, oral cavity, oropharynx, unknown primary with HPV pos, larynx and hy-popharynx) and candidated to curative non surgical treatment (radiotherapy alone, Chemora-diation with platinum salts; radiation+cetuximab)
• Evaluable disease accordingly to RECIST criteria 1.1
• Willing of sign a written informed consent
• Adequate organ function

Exclusion criteria

Patient with cancer in other sites than HN < than 2 years except for prostate cancer cT1-2, Gleason 3+3, NIMBC, initial Non Melanoma Skin Cancer, in situ cervical cancer)

• PS ECOG 3-4
• Patients who received systemic treatments in the past for other primary tumors