Skip to content

Predicting Toxicity in Elderly Patients With Head and Neck Cancer

Predicting Toxicity in Elderly Patients With Head and Neck Cancer: Validating a Disease-oriented Toxicity Predictive Tool and Integrating it With Available Screening Tools for Better Outcomes

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06344208
Acronym
PREtoxEL
Enrollment
3
Registered
2024-04-03
Start date
2022-03-15
Completion date
2026-12-31
Last updated
2026-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancer

Brief 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.

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.

Interventions

None listed

Sponsors

European Institute of Oncology
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
70 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Predicting toxicity in elderly patients with head and neck cancer2 yearsvalidating a disease-oriented toxicity predictive tool and integrating it with avail-able screening tools for better outcomes

Countries

Italy

Contacts

CONTACTMaria Cossu Rocca, MD
maria.cossurocca@ieo.it00390294372900
CONTACTfrancesca lombardi
francesca.lombardi@ieo.it00390257489425

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 25, 2026