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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer

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.

• Study Type: Observational
• Enrollment (Estimated): 3

Contacts and Locations

• Study Contact: Name: maria Cossu Rocca, MD; Phone Number: 00390294372900; Email: maria.cossurocca@ieo.it
• Study Contact Backup: Name: francesca lombardi; Phone Number: 00390257489425; Email: francesca.lombardi@ieo.it

Study Locations

• Italy
  • Milan
    • Milan, Milan, Italy, 20141
      • Recruiting
      • European Institute of Oncology
      • Contact: maria Cossu Rocca, MD; Phone Number: 00390294372900; Email: maria.cossurocca@ieo.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	2 years

Collaborators and Investigators

• Sponsor: European Institute of Oncology

Study record dates

Study Major Dates

• Study Start (Actual): March 15, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 27, 2024
• First Submitted That Met QC Criteria: March 27, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms
• Other Study ID Numbers: IEO 1647

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No