Head and Neck Cancer
Conditions
Keywords
Head and Neck Cancer, Exclusive Radiotherapy
Brief summary
This is a prospective cohort study for the analysis of correlation between dosimetric parameters and RANV (Radiation Associated Nausea and Vomiting) in patients with head and neck cancer undergoing exclusive radiotherapy (RT). The primary purpose of this study is to search for a potential correlation between dosimetry and physician- and patient-rated symptoms in patients treated with exclusive radiotherapy for head and neck cancer.
Detailed description
The use of Intensity Modulated Radiation Therapy (IMRT) has become increasingly common in clinical practice for the treatment of head and neck tumors. Despite the well-documented dosimetric advantages of IMRT, there has been a gradual recognition of toxicity profiles that are characteristic and distinct from those known in the era of 2D and 3D techniques, associated with the so-called dose bath typical of all intensity-modulated treatments. Among these, one of the main concerns is Radiation-Associated Nausea and Vomiting (RANV), the persistence and severity of which can significantly compromise the quality of life for patients. Consequently, there has been a growing need to more thoroughly assess the clinical and dosimetric risk factors associated with the onset of RANV in this population. Although several authors have already investigated this aspect, most studies available to date consider cases where concurrent chemotherapy administration may affect the assessment of the outcomes of interest. Even when exclusively focusing on studies centered on IMRT (without concurrent chemotherapy), the generalization of results is at least partially affected by the fact that these are retrospective series with a relatively small population (23-130 patients).
Interventions
RADIATIONExclusive radiotherapy
Curative radiotherapy treatment using 3D conformal or Intensity Modulated Radiation Therapy (IMRT) techniques.
Sponsors
European Institute of Oncology
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients aged ≥ 18 years * Diagnosis of primary head and neck neoplasm in the following subsites: oropharynx, nasopharynx, oral cavity, paranasal sinuses, salivary glands, and neoplasms with an unknown primary focus. * Curative radiotherapeutic treatment with photons or protons using 3D conformal or Intensity Modulated Radiation Therapy (IMRT), Volumetric Modulated Arc Therapy (VMAT), Tomotherapy; both photon and proton treatments are allowed. * Ability to prospectively collect and anonymously submit clinical data related to the patient, pathology, and treatment characteristics (including the radiotherapy treatment plan in RT.dose format) to a single referring center. * Ability to prospectively collect and anonymously submit DICOM (Digital Imaging and COmmunication in Medicine) files related to pre-RT magnetic resonance imaging (MRI) to a single referring center. * Ability to collect acute toxicity data (mucositis, xerostomia, nausea, vomiting, weight loss) during radiotherapy and at three months post-treatment. * Ability to undergo a clinical follow-up examination three months after the completion of radiotherapy. * Willingness to provide written informed consent for the anonymous use of data for research purposes.
Exclusion criteria
* Patients undergoing chemotherapy treatment (neoadjuvant or concurrent with radiotherapy). * Patients with local and/or locoregional recurrence of head and neck disease. * Patients previously treated with oncologic interventions in the head and neck region. * Patients with synchronous distant metastases at the time of diagnosis. * Inability to comprehensively collect baseline data related to the patient, pathology, and treatment characteristics (including the treatment plan) and follow-up data. * Inability to obtain written informed consent for the anonymous use of data for research purposes.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of nausea (acute toxicity) using CTCAE V5.0 | 3 months | Dose-response correlation between central nervous system (CNS) structures and substructures and nausea (Nausea will be scored using Common Terminology Criteria for Adverse Events- CTCAE- v 5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of nausea (acute toxicity) using M.D. Anderson Symptom Inventory (MDASI-SCORE) questionnaire | 3 months | Dose-response correlation between central nervous system (CNS) structures and substructures and nausea evaluated by MDASI-CORE questionnaire |
| Identification of the organs at risk most strongly correlated with the onset of nausea | 3 months | Identification of the organs at risk most strongly correlated with the onset of nausea, both through the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (physician-rated outcome) and the MDASI-CORE questionnaire (patient-reported outcomes) |
| Identification of dosimetric cutoffs for the onset of nausea | 3 months | Identification of dosimetric cutoffs for the onset of nausea using Normal Tissue Complication Probability (NTCP) models |
| Comparison of dosimetric analysis between 3D conformal, IMRT and proton therapy techniques | 3 months | Dosimetric analysis comparing 3D conformal, IMRT, and proton therapy techniques, with a specific focus on the onset of nausea. Evaluation will be conducted using both the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 and the MDASI-CORE questionnaire |
| Development of machine-learning predictive models for the onset of nausea | 1 year | Development of machine-learning predictive models for the onset of nausea, incorporating clinical, dosimetric, and imaging parameters |
Countries
Italy
Contacts
Primary ContactStefania Volpe, MD
Outcome results
None listed