Predictive Tools in Head and Neck Cancer Patients Undergoing Radiotherapy

NCT06806683 | Active Not Recruiting

• 1 other identifier: 6698
• Study Type: observational
• Target: 915
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Cancer Recurrence

  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

Interventions

intensity modulated radiotherapy RADIATION

intensity modulated radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Lazio, 00168, Italy

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Mouth Neoplasms; Oropharyngeal Neoplasms

Interventions

Radiotherapy, Intensity-Modulated

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Radiotherapy, Conformal; Radiotherapy, Computer-Assisted; Radiotherapy; Therapeutics

Study Officials

• Mariangela Massaccesi, MD

  Fondazione Policlinico Universitario A. Gemelli, IRCCS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: February 4, 2025
• Study Start: January 1, 2023
• Primary Completion (Estimated): December 31, 2034
• Study Completion (Estimated): December 1, 2039
• Last Updated: February 4, 2025

Record last verified: 2024-10

Locations

IT (1)