Predicting Toxicity in Elderly Patients With Head and Neck Cancer

NCT06344208 | Recruiting

• 1 other identifier: IEO 1647
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Head and Neck Cancer

Outcome Measures

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

  2 years

Eligibility Criteria

• Age: 70 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology

Milan, Milan, 20141, Italy

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Central Study Contacts

Maria Cossu Rocca, MD

CONTACT

00390294372900; maria.cossurocca@ieo.it

francesca lombardi

CONTACT

00390257489425; francesca.lombardi@ieo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 3, 2024
• Study Start: March 15, 2022
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

IT (1)