Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Evaluate the correlation of therapy response
- timeFrame
- From enrollment to the last follow-up at 12 months
- description
- 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
Secondary outcomes (6)
- measure
- Acute toxicity
- timeFrame
- immediate to 6 months after radiotherapy
- description
- acute toxicity after radiotherapy, evaluated according to CTCAE v.5
- measure
- Late toxicity
- timeFrame
- from 6 months after radiotherapy, through study completion, an average of 1 year
- description
- late toxicity after completion of treatments, evaluated according to CTCAE v.5
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available