Ignite Creation Date:
2024-05-06 @ 8:05 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06248996
Status:
RECRUITING
Last Update Posted:
2024-02-08
First Post:
2024-01-31
Brief Title:
a Multicentre Phase III Study of Risk-based Treatment Intensification With Hyperfractionated Radiotherapy in Head and Neck Cancer Patients
Sponsor:
Lund University Hospital
Organization:
Lund University Hospital
Study Overview
Official Title:
ARTSCAN VI Protocol Version 1 2023-07-03 ARTSCAN VI - a Multicentre Phase III Study of Risk-based Treatment Intensification With Hyperfractionated Radiotherapy in Head and Neck Cancer Patients
Status:
RECRUITING
Status Verified Date:
2024-09
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:
ARTSCAN VI
Brief Summary:
There is an unmet need to personalise treatment for patients with head and neck squamous cell carcinoma HNSCC and to improve treatment results for patients with advanced disease In this phase III study HNSCC patients with prognostic factors indicating increased risk of treatment failure that are aimed for curative treatment with radiotherapy RT will be randomised between standard treatment conventionally fractionated RT with final RT dose 680 Gy and hyperfractionated RT HFX-RT with final RT dose 830 Gy
In order to find better prognostic and predictive tools the study also includes exploratory and translational analyses including evaluation of grade of hypoxia with Magnetic Resonance Imaging MRI and gene profiling by RNA-sequencing tumour immune profiling comparisons of global gene expression gene aberrations and protein expression and texture analyses of CT FDG-PET and MRI images used during RT preparation and during patient follow-up Patients with tumours with lower risk of recurrence not eligible for randomisation in the study can still participate in the translational parts of the study not investigating response to altered fractionation
In order to find better prognostic and predictive tools the study also includes exploratory and translational analyses including evaluation of grade of hypoxia with Magnetic Resonance Imaging MRI and gene profiling by RNA-sequencing tumour immune profiling comparisons of global gene expression gene aberrations and protein expression and texture analyses of CT FDG-PET and MRI images used during RT preparation and during patient follow-up Patients with tumours with lower risk of recurrence not eligible for randomisation in the study can still participate in the translational parts of the study not investigating response to altered fractionation
Detailed Description:
None
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