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

January 31, 2025 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

915

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • Lazio
      • Rome, Lazio, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cancer Recurrence
Time Frame: 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.
From enrollment to 36 months post-treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Mariangela Massaccesi, MD, Fondazione Policlinico Universitario A. Gemelli, IRCCS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Estimated)

December 31, 2034

Study Completion (Estimated)

December 1, 2039

Study Registration Dates

First Submitted

October 21, 2024

First Submitted That Met QC Criteria

January 31, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 31, 2025

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6698

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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