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Active, Not Recruiting

NCT Number: NCT06806683

Predictive Tools in Head and Neck Cancer Patients Undergoing Radiotherapy

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intensity modulated radiotherapy

Radiation

intensity modulated radiotherapy

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: ITHACA

Important dates

Study start
2023
Primary completion
2034
Study completion
2039
First posted
Feb 4, 2025
Registry last updated
Feb 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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