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NCT Number: NCT06344208

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 avail-able screening tools for better outcomes.

Recruiting

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Key information

Age range

70 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

European Institute of Oncology

Milan, 20141, Italy

Location status: Recruiting

Location contact

maria Cossu Rocca, MD

CONTACT

[email protected]

00390294372900

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Predicting toxicity in elderly patients with head and neck cancer

    Time frame: 2 years

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

Study contacts

Contact information is provided by the study sponsor or research team.

Maria Cossu Rocca, MD

CONTACT

[email protected]

00390294372900

francesca lombardi

CONTACT

[email protected]

00390257489425

Sponsors and collaborators

Lead sponsor

European Institute of Oncology

Other

Registry information

Official study title

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

Acronym: PREtoxEL

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Apr 3, 2024
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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