Clinical trial NCT06806683: Predictive Tools in Head and Neck Cancer Patients Undergoing Radiotherapy
Official title: ITHACA: Development and Validation of a Multivariate Predictive Model for Prognosis in Head and Neck Cancer Patients Undergoing Radiotherapy - Ambispective Study.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
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
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-02-04
Enrollment: 915
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study includes adult patients (≥18 years old) diagnosed with head and neck cancers. Patients are eligible if they are undergoing or scheduled to undergo radiotherapy or chemoradiotherapy in one of the following settings: definitive (primary treatment), adjuvant (post-surgical), or palliative (symptom relief or disease control). The study aims to evaluate treatment effectiveness and monitor side effects across a diverse patient cohort.

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.


Eligibility 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.

Primary outcomes:
measure: Cancer Recurrence
timeFrame: From enrollment to 36 months post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
state: Lazio
Study officials:
affiliation: Fondazione Policlinico Universitario A. Gemelli, IRCCS
name: Mariangela Massaccesi, MD
role: PRINCIPAL_INVESTIGATOR
References: