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Clinical Trials in Italy / NCT06806683
Active, not recruiting Observational

Predictive Tools in Head and Neck Cancer Patients Undergoing Radiotherapy

NCT06806683 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Phase
Observational
Started
2023-01-01
Last updated
2025-02-04

Condition(s) studied

Head and Neck CancersHead and Neck Cancers - NasopharyngealOral Cavity CancerOropharyngeal CancersRadiotherapy Side Effects

Investigational drug(s) / intervention(s)

intensity modulated radiotherapy

intensity modulated radiotherapy: intensity modulated radiotherapy

Study summary

The ITHACA study aims to improve the treatment of head and neck cancer by developing a predictive tool that helps doctors personalize care for each patient. This tool uses information such as medical history, imaging, and radiotherapy data to predict the risk of cancer recurrence, overall survival, and the likelihood of side effects.

Patients with head and neck cancer face significant challenges, including managing the side effects of treatments like radiotherapy. By tailoring treatment schedules and doses, and using advanced imaging techniques, we hope to reduce complications and improve survival outcomes. The study is designed to help doctors choose the best treatment for each patient, while minimizing the side effects that impact important functions like swallowing and breathing.

Patients participating in the study will have their medical data collected, including:

Tumor characteristics (size, location, stage). Treatment details (radiotherapy and chemotherapy). Imaging information using tools like PET-CT and MRI to track the response to treatment and detect any signs of cancer recurrence.

Side effects and overall health data. This information will be used to develop and test a new model that predicts outcomes for each patient based on their unique data.

The study includes adults (18 years and older) diagnosed with head and neck cancer, who are undergoing or have completed radiotherapy. Patients will be followed over time to monitor their response to treatment and any side effects.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria Participants must meet all of the following criteria: * Diagnosis: Confirmed head and neck cancer, including cancers of the oropharynx, larynx, hypopharynx, nasopharynx, salivary gland, unknown head and neck primary or oral cavity. * Age: 18 years or older. * Treatment: Undergoing or scheduled to undergo radiotherapy or chemoradiotherapy as part of their treatment Exclusion Criteria Participants will be excluded if they meet any of the following criteria: * Pregnancy: Pregnant or breastfeeding women. * Non-Compliance: Patients unwilling or unable to comply with study procedures and follow-ups.

Primary outcome measure(s)

  • Cancer Recurrence — From enrollment to 36 months post-treatment
    The main focus is the probability of recurrence of head and neck cancer after the completion of radiotherapy. This will be assessed at various intervals, specifically at 3, 6, 12, 24, and 36 months post-treatment, using imaging techniques such as PET-CT, MRI, and CT, along with clinical evaluations.

Trial sites (1)

FacilityCityRegionStatus
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Lazio

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06806683 on ClinicalTrials.gov ↗ ← All trials in Italy