DOsimetry and Radiation Induced NAusea in Head and Neck Cancers

Head and Neck Cancer Clinical Trial

— DORIAN  

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06341985
• Other study ID #: IEO 1593
• Status: Recruiting
• Start date: November 15, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: European Institute of Oncology
• Contact: Stefania Volpe, MD
• Phone: +3902574892418
• Email: stefania.volpe[@]ieo.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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). 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 180
• Est. completion date: December 31, 2024
• Est. primary completion date: November 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

Radiation:
• Exclusive radiotherapy
Curative radiotherapy treatment using 3D conformal or Intensity Modulated Radiation Therapy (IMRT) techniques.

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona	Ancona
Italy	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 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

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 months
Secondary	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	3 months
Secondary	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)	3 months
Secondary	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	3 months
Secondary	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	3 months
Secondary	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	1 year