Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06341985
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-03-18
Brief Title:
DOsimetry and Radiation Induced NAusea in Head and Neck Cancers
Sponsor:
European Institute of Oncology
Organization:
European Institute of Oncology
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DORIAN
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None