Predictive Tools in Head and Neck Cancer Patients Undergoing Radiotherapy (ITHACA)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Active, not recruiting

Conditions: Head and Neck Cancers - Nasopharyngeal; Radiotherapy Side Effects; Oral Cavity Cancer; Head and Neck Cancers; Oropharyngeal Cancers

Treatments: Radiation: intensity modulated radiotherapy

Study type: Observational

Funder types: Other

Identifiers

NCT06806683

6698

Details and patient eligibility

About

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.

Enrollment: 915 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design