DOsimetry and Radiation Induced NAusea in Head and Neck Cancers (DORIAN)

March 26, 2024 updated by: European Institute of Oncology

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

180

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Exclusive Radiotherapy Treatment
Curative radiotherapy treatment using 3 Dimension (3D) conformal or Intensity Modulated Radiation Therapy (IMRT) techniques.
Radiation: Exclusive radiotherapy
Curative radiotherapy treatment using 3D conformal or Intensity Modulated Radiation Therapy (IMRT) techniques.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of nausea (acute toxicity) using M.D. Anderson Symptom Inventory (MDASI-SCORE) questionnaire
Time Frame: 3 months
Dose-response correlation between central nervous system (CNS) structures and substructures and nausea evaluated by MDASI-CORE questionnaire
3 months
Identification of the organs at risk most strongly correlated with the onset of nausea
Time Frame: 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)
3 months
Identification of dosimetric cutoffs for the onset of nausea
Time Frame: 3 months
Identification of dosimetric cutoffs for the onset of nausea using Normal Tissue Complication Probability (NTCP) models
3 months
Comparison of dosimetric analysis between 3D conformal, IMRT and proton therapy techniques
Time Frame: 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
3 months
Development of machine-learning predictive models for the onset of nausea
Time Frame: 1 year
Development of machine-learning predictive models for the onset of nausea, incorporating clinical, dosimetric, and imaging parameters
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Institute of Oncology

Investigators

  • Principal Investigator: Stefania Volpe, MD, European Institute of Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2021

Primary Completion (Estimated)

November 15, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

March 18, 2024

First Submitted That Met QC Criteria

March 26, 2024

First Posted (Actual)

April 2, 2024

Study Record Updates

Last Update Posted (Actual)

April 2, 2024

Last Update Submitted That Met QC Criteria

March 26, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IEO 1593

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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