Predicting toxicity in elderly patients with head and neck cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to create and validate a predictive score that identifies the likelihood of severe toxicity (G3-5) in elderly patients diagnosed with head and neck cancer who are candidates for curative treatment. By analyzing clinical and biochemical variables, the research seeks to integrate this predictive tool with existing screening methods to improve patient outcomes. The focus is on patients aged 70 and older with specific types of head and neck cancer undergoing radiation therapy or chemoradiation. The study is observational and does not involve any experimental interventions.

Why it matters

Who can join: the full rules

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

Where it's running

• European Institute of Oncology
  Milan, Milan, Italy Recruiting

Study contacts

• Study coordinator: Maria Cossu Rocca, MD
• Email: maria.cossurocca@ieo.it
• Phone: 00390294372900

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.