DOsimetry and Radiation Induced NAusea in Head and Neck Cancers
NCT ID: NCT06341985
Last Updated: 2024-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
180 participants
OBSERVATIONAL
2021-11-15
2024-12-31
Brief Summary
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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.
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Detailed Description
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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).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Exclusive Radiotherapy Treatment
Curative radiotherapy treatment using 3 Dimension (3D) conformal or Intensity Modulated Radiation Therapy (IMRT) techniques.
Exclusive radiotherapy
Curative radiotherapy treatment using 3D conformal or Intensity Modulated Radiation Therapy (IMRT) techniques.
Interventions
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Exclusive radiotherapy
Curative radiotherapy treatment using 3D conformal or Intensity Modulated Radiation Therapy (IMRT) techniques.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
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European Institute of Oncology
OTHER
Responsible Party
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Principal Investigators
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Stefania Volpe, MD
Role: PRINCIPAL_INVESTIGATOR
European Institute of Oncology
Locations
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Ospedale "Mons. Dimiccoli"
Barletta, , Italy
Azienda Ospedaliera S.Pio
Benevento, , Italy
Ospedale MultiMedica
Castellanza, , Italy
IRCCS Ospedale Policlinico San Martino
Genova, , Italy
European Institute of Oncology
Milan, , Italy
IRCCS Ospedale San Raffaele
Milan, , Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
Ancona, , Italy
Azienda Ospedaliero-Universitaria di Modena
Modena, , Italy
Azienda Ospedaliero Universitaria Ospedale Maggiore della Carità di Novara
Novara, , Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, , Italy
Azienda Ospedaliera Complesso Ospedaliero San Giovanni - Addolorata
Roma, , Italy
Azienda Ospedaliero Universitaria Policlinico Umberto I
Roma, , Italy
Ospedale San Giovanni Calibita Fatebenefratelli Isola Tiberina
Roma, , Italy
I.R.C.C.S. MultiMedica - Sesto San Giovanni
Sesto San Giovanni, , Italy
Countries
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Central Contacts
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Facility Contacts
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Stefania Volpe
Role: primary
Other Identifiers
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IEO 1593
Identifier Type: -
Identifier Source: org_study_id
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