Predictive Tools in Head and Neck Cancer Patients Undergoing Radiotherapy

ITHACA: Development and Validation of a Multivariate Predictive Model for Prognosis in Head and Neck Cancer Patients Undergoing Radiotherapy - Ambispective Study.

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06806683

Acronym

ITHACA

Enrollment

915

Registered

2025-02-04

Start date

2023-01-01

Completion date

2039-12-31

Last updated

2025-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Cancers, Head and Neck Cancers - Nasopharyngeal, Oral Cavity Cancer, Oropharyngeal Cancers, Radiotherapy Side Effects

Keywords

Head and neck cancer, Radiotherapy, Chemoradiotherapy, Radiomics, Personalized treatment, Dosiomics

Brief 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.

Interventions

RADIATIONintensity modulated radiotherapy

intensity modulated radiotherapy

Study design

Observational model

COHORT

Time perspective

OTHER

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026