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RecruitingNCT06344208PREtoxELUpdated Mar 24, 2026

Predicting Toxicity in Elderly Patients With Head and Neck Cancer

An observational study in Head and Neck Cancer, sponsored by European Institute of Oncology. Recruiting at 1 site in Italy. Open to participants aged 70 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-03-24.

Sponsored by European Institute of Oncology · Observational

From the registry’s dates

  • Started Mar 2022; still recruiting 4 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3
Ages
70 Years to 99 Years
Sex
All
01

Study summary

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.

Read the detailed 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.

02

Conditions studied

  • Head and Neck Cancer
03

In context

Head and Neck Neoplasms

2,344 studies on the registry are indexed under Head and Neck Neoplasms; 551 are open to participants now.

This study's planned enrollment of 3 is below the median of 100 across 441 observational studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

European Institute of Oncology is the lead sponsor of 178 studies on the registry; 113 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
70 Years to 99 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

300 pts from the outpa-tients oncology practice previously discussed at multisciplinary meeting (MD) All the patients with age ≥ 70 years old, diagnosed with HNC candidated to a curative treatment with radiotherapy +/- systemic therapy (chemotherapy or cetuximab) will be evaluated.

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 2 years

07

Study locations

1 of 1 sites recruiting
  • European Institute of Oncology
    Milan, Milan 20141, Italy
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06344208
Lead sponsor
European Institute of Oncology
Responsible party
Sponsor
First posted
Apr 3, 2024
Start date
Mar 15, 2022
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Mar 24, 2026

Study contacts

Maria Cossu Rocca, MD
Contact
maria.cossurocca@ieo.it
00390294372900
francesca lombardi
Contact
francesca.lombardi@ieo.it
00390257489425

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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