Assessment of Different Therapeutic Strategies in Patients With Head and Neck Neoplasms Treated With Radiotherapy

Assessment of Toxicity and Outcomes of Different Therapeutic Strategies in Patients With Head and Neck Neoplasms Treated With Radiotherapy at the IRCCS Azienda Ospedaliero-Universitaria di Bologna

This is a monocentric observational study aimed at collecting data related to the radiotherapy treatment of head and neck neoplasms. The purpose of the study is to systematically gather data on radiotherapy for head and neck neoplasms to evaluate tumor response and potential toxicity in relation to dosages and techniques used, the combination with other therapies, disease characteristics, and the psychological impact of the proposed treatments.

Additionally, collecting data on both disease characteristics and pre-existing conditions in a large sample may allow for the assessment of any correlation with radiation-induced toxicities, with the goal of predicting and preventing them in a personalized manner in the future.

The study's aim is thus to evaluate tumor response and any potential toxicity following radiotherapy treatment concerning treatment modalities, dosages, and techniques used, for both new diagnoses and cases already diagnosed and treated since January 1, 2000, at the Radiotherapy Unit of the S. Orsola-Malpighi Polyclinic. The structured data collection necessary for evaluating the objectives will cover the observation period from January 1, 2000, to December 15, 2030, involving approximately 3,000 patients. Participation in the study solely involves the structured collection of certain information already present in your medical records, as well as data related to clinical exams, radiological imaging, and therapies, without any modifications to standard clinical practice. Participation in the study incurs no costs and will not be compensated in any way. There are no risks or inconveniences associated with participating in this study. Enrolled patients will not receive any direct benefit from this study, as it is purely a data collection effort. The collected data will enhance understanding of the factors associated with treatment outcomes, ultimately leading to improved management of each individual patient.

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer

Detailed Description

Head and neck tumors refer to neoplasms that originate in the nasal cavities and paranasal sinuses, rhinopharynx/oropharynx/hypopharynx, salivary glands, oral cavity, and larynx, mostly represented by squamous cell carcinomas. Head and neck tumors account for 4.9% of all malignant tumors worldwide.

Treatment is mostly multimodal; the main therapeutic options include surgery, systemic therapy, and radiotherapy. Various treatments may serve as primary or adjuvant therapy depending on the specific neoplasm and the strategy adopted.

Regarding radiotherapy, it is often used in combination with other treatments depending on the stage, location of the disease, risk factors, or in a palliative setting. Dosages, fractionation, and techniques vary based on the type of neoplasm being treated and the purpose of the therapy (adjuvant, radical, palliative), as do the possible acute and late toxicities related to the treatment characteristics.

The purpose of the study is to systematically collect data related to radiotherapy treatment in head and neck neoplasms in order to evaluate outcomes in relation to dosages, fractionation, and techniques used, as well as combinations with other therapies and disease characteristics. Additionally, collecting data on both disease characteristics and treatments in a large sample may enable the assessment of any potential correlation with radiation-induced toxicities, allowing for future prediction and personalized prevention.

Enrolled patients will not have any direct benefit or harm from their participation in the study, as it is solely a data collection effort. Conversely, these data may lead to new insights that improve the management of the analyzed neoplastic diseases in the future.

The study thus aims to evaluate outcomes, toxicity, and the psychological impact on patients related to radiotherapy treatment concerning treatment settings, dosages, and techniques used, for both new diagnoses and cases already diagnosed and treated since January 1, 2000, at the Radiotherapy Unit of the S. Orsola Polyclinic. The structured data collection necessary for evaluating the objectives will cover the observation period from January 1, 2000, to December 15, 2030, involving approximately 3,000 patients (2,000 for the retrospective phase and 1,000 for the prospective phase).

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Alessio Giuseppe Morganti, MD; Phone Number: +39 0516363136; Email: alessio.morganti2@unibo.it

Study Locations

• Italy
  • Bologna, Italy, 40138
    • Recruiting
    • IRCCS Azienda Ospedaliero - Universitaria di Bologna
    • Contact: Alessio Giuseppe Morganti, MD; Phone Number: +39 0516363136; Email: alessio.morganti2@unibo.it
    • Principal Investigator: Alessio Giuseppe Morganti, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with new or previous diagnosis of malignant neoplasm of the head and neck

Description

Inclusion Criteria:

• Patients of both sexes, aged ≥ 18 years, with new or previous diagnosis of malignant neoplasm of the head and neck, from January 1, 2000, treated at the Radiotherapy Unit of the S. Orsola Polyclinic
• Obtaining informed consent

Exclusion Criteria:

• None

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the correlation of therapy response	Evaluate the correlation of therapy response with other parameters in the radiotherapy treatment of head and neck neoplasms, considering the treatment setting, dosages, and techniques used	From enrollment to the last follow-up at 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall survival		From enrollment to the last follow-up at 12 months
Acute toxicity	acute toxicity after radiotherapy, evaluated according to CTCAE v.5	immediate to 6 months after radiotherapy
Late toxicity	late toxicity after completion of treatments, evaluated according to CTCAE v.5	from 6 months after radiotherapy, through study completion, an average of 1 year
Impact on the patient's quality of life	The impact on patients' quality of life will be assessed through the submission of questionnaires (FACT H&N)	From enrollment to the last follow-up at 12 months
Retreatments	Retreatments yes or not	During the follow-ups, up to the last one at 12 months
Disease-free survival	Disease-free survival assessed based on the presence or absence of local, nodal, or metastatic recurrences	During the follow-ups, up to the last one at 12 months

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Investigators: Principal Investigator: Alessio Giuseppe Morganti, MD, IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Actual): October 28, 2021
• Primary Completion (Estimated): November 15, 2030
• Study Completion (Estimated): December 15, 2030

Study Registration Dates

• First Submitted: December 1, 2024
• First Submitted That Met QC Criteria: January 8, 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 8, 2025
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Head and Neck Neoplasms
• Other Study ID Numbers: PORTO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No