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NCT06344208 Clinical Trial

Predicting Toxicity in Elderly Patients With Head and Neck Cancer

Head and Neck Cancer Clinical Trial

— PREtoxEL  

Official 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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06344208
Other study ID # IEO 1647
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 15, 2022
Est. completion date December 31, 2024

Study information
Verified date March 2024
Source European Institute of Oncology
Contact Maria Cossu Rocca, MD
Phone 00390294372900
Email maria.cossurocca@ieo.it
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 3
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group 70 Years to 99 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Locations
Country Name City State
Italy European Institute of Oncology Milan MI

Sponsors (1)
Lead Sponsor Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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