Head and Neck CancerDORIANNCT06341985
DOsimetry and Radiation Induced NAusea in Head and Neck Cancers
An observational study of Head and Neck Cancer, run by European Institute of Oncology at 14 sites in Italy.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Exclusive radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 180 participants
- Where
- 14 sitesItaly
- Study dates
- 15 Nov 2021to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with head and neck neoplasms (early or locally advanced stage) treated solely with curative radiotherapy, having undergone contrast-enhanced magnetic resonance imaging (MRI), and for whom acute toxicity data are available.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
Italy14 sites, 14 recruiting
- Recruiting
Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona
Ancona
Giovanna Mantello, clelia.dicarlo@ospedaliriuniti.marche.it
- Recruiting
Ospedale "Mons. Dimiccoli"
Barletta
Alessia Di Rito, aledirito@yahoo.it
- Recruiting
Azienda Ospedaliera S.Pio
Benevento
Angela Argenone, angela.argenone@ao-rummo.it
- Recruiting
Ospedale MultiMedica
Castellanza
Gianpiero Catalano, gianpiero.catalano@multimedica.it
- Recruiting
IRCCS Ospedale Policlinico San Martino
Genova
Liliana Belgioia, liliana.belgioia@unige.it
- Recruiting
European Institute of Oncology
Milan
Stefania Volpe
- Recruiting
IRCCS Ospedale San Raffaele
Milan
Italo Dell'Oca, delloca.italo@hsr.it
- Recruiting
Azienda Ospedaliero-Universitaria di Modena
Modena
Elisa D'Angelo, dangelo.elisa@policlinico.mo.it
- Recruiting
Azienda Ospedaliero Universitaria Ospedale Maggiore della Carità di Novara
Novara
Carla Pisani, carla.pisani@maggioreosp.novara.it
- Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia
Sara Colombo, s.colombo@smatteo.pv.it
- Recruiting
Azienda Ospedaliera Complesso Ospedaliero San Giovanni - Addolorata
Roma
Giuseppina Apicella, gapicella@hsangiovanni.roma.it
- Recruiting
Azienda Ospedaliero Universitaria Policlinico Umberto I
Roma
Francesca De Felice, francesca.defelice@uniroma1.it
- Recruiting
Ospedale San Giovanni Calibita Fatebenefratelli Isola Tiberina
Roma
Orietta Caspiani, o.caspiani@gmail.com
- Recruiting
I.R.C.C.S. MultiMedica - Sesto San Giovanni
Sesto San Giovanni
Gianpiero Catalano, gianpiero.catalano@multimedica.it
About this study
Official title: Prospective Multicenter 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)
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.
Read the 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).
- Conditions
- Head and Neck Cancer
- Being tested
- Exclusive radiotherapy
- Keywords
- Head and Neck Cancer, Exclusive Radiotherapy
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exclusive radiotherapyRadiation
Curative radiotherapy treatment using 3D conformal or Intensity Modulated Radiation Therapy (IMRT) techniques.
| Study group | Role | What they receive |
|---|---|---|
| Exclusive Radiotherapy Treatment | Curative radiotherapy treatment using 3 Dimension (3D) conformal or Intensity Modulated Radiation Therapy (IMRT) techniques. Receives: Radiation: Exclusive radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of nausea (acute toxicity) using CTCAE V5.0
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
Measured: 3 months
Secondary outcomes (5)
Evaluation of nausea (acute toxicity) using M.D. Anderson Symptom Inventory (MDASI-SCORE) questionnaire
Dose-response correlation between central nervous system (CNS) structures and substructures and nausea evaluated by MDASI-CORE questionnaire
Measured: 3 months
Identification of the organs at risk most strongly correlated with the onset of nausea
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)
Measured: 3 months
Identification of dosimetric cutoffs for the onset of nausea
Identification of dosimetric cutoffs for the onset of nausea using Normal Tissue Complication Probability (NTCP) models
Measured: 3 months
Comparison of dosimetric analysis between 3D conformal, IMRT and proton therapy techniques
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
Measured: 3 months
Development of machine-learning predictive models for the onset of nausea
Development of machine-learning predictive models for the onset of nausea, incorporating clinical, dosimetric, and imaging parameters
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start15 Nov 2021
- Primary completion15 Nov 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefania Volpe, MD, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06341985
- Sponsor's protocol ID
- IEO 1593
- Acronym
- DORIAN
- Status last verified
- Mar 2024
- First submitted
- 18 Mar 2024
- Last updated
- 2 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Multicenter 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)
- ClinicalTrials.gov ID
- NCT06341985
- Acronym / sponsor ID
- DORIAN / IEO 1593
- Conditions
- Head and Neck Cancer
- Keywords
- Head and Neck Cancer, Exclusive Radiotherapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 15 Nov 2021 (actual)
- Primary completion
- 15 Nov 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exclusive Radiotherapy Treatment | – | Radiation: Exclusive radiotherapyCurative radiotherapy treatment using 3 Dimension (3D) conformal or Intensity Modulated Radiation Therapy (IMRT) techniques. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with head and neck neoplasms (early or locally advanced stage) treated solely with curative radiotherapy, having undergone contrast-enhanced magnetic resonance imaging (MRI), and for whom acute toxicity data are available.
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exclusive radiotherapyCurative radiotherapy treatment using 3D conformal or Intensity Modulated Radiation Therapy (IMRT) techniques. | Radiation | Exclusive Radiotherapy Treatment |
Primary outcome
Evaluation of nausea (acute toxicity) using CTCAE V5.0
Time frame: 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
5 secondary outcomes
Evaluation of nausea (acute toxicity) using M.D. Anderson Symptom Inventory (MDASI-SCORE) questionnaire
Time frame: 3 months
Identification of the organs at risk most strongly correlated with the onset of nausea
Time frame: 3 months
Identification of dosimetric cutoffs for the onset of nausea
Time frame: 3 months
Comparison of dosimetric analysis between 3D conformal, IMRT and proton therapy techniques
Time frame: 3 months
Development of machine-learning predictive models for the onset of nausea
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stefania Volpe, MD principal investigator
European Institute of Oncology
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer, run by European Institute of Oncology at 14 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stefania Volpe, MD (+3902574892418, stefania.volpe@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of nausea (acute toxicity) using CTCAE V5.0 (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2024.