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
European Institute of Oncology · NCT06344208
This study is trying to create a score to help doctors predict if older patients with head and neck cancer will have serious side effects from their treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 3 (estimated) |
| Ages | 70 Years to 99 Years |
| Sex | All |
| Sponsor | European Institute of Oncology (other) |
| Drugs / interventions | cetuximab, radiation |
| Locations | 1 site (Milan, Milan) |
| Trial ID | NCT06344208 on ClinicalTrials.gov |
What this trial studies
This study aims to create and validate a predictive score that identifies the likelihood of severe toxicity (G3-5) in elderly patients diagnosed with head and neck cancer who are candidates for curative treatment. By analyzing clinical and biochemical variables, the research seeks to integrate this predictive tool with existing screening methods to improve patient outcomes. The focus is on patients aged 70 and older with specific types of head and neck cancer undergoing radiation therapy or chemoradiation. The study is observational and does not involve any experimental interventions.
Who should consider this trial
Good fit: Ideal candidates for this study are patients aged 70 years and older with advanced head and neck cancer who are eligible for curative non-surgical treatments.
Not a fit: Patients with head and neck cancer who have received prior systemic treatments for other primary tumors or have a poor performance status may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better management of treatment-related toxicity in elderly patients with head and neck cancer.
How similar studies have performed: Other studies have explored predictive tools for treatment toxicity, but this specific approach focusing on elderly patients with head and neck cancer is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Milan, Milan
- European Institute of Oncology — Milan, Milan, Italy (RECRUITING)
Study contacts
- Study coordinator: Maria Cossu Rocca, MD
- Email: maria.cossurocca@ieo.it
- Phone: 00390294372900
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Head and Neck Cancer