Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06516133
Status:
RECRUITING
Last Update Posted:
None
First Post:
2023-12-27
Brief Title:
Online Adaptive Radiotherapy for Nasopharyngeal Carcinoma
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Artificial Intelligence Empowered Online Adaptive Radiotherapy Versus Conventional Radiotherapy in Non-metastatic Nasopharyngeal Carcinoma an Open-label Non-inferiority Multicentre Randomised Phase 3 Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OART
Brief Summary:
In this multicenter prospective randomized controlled non-inferiority Phase III clinical trial treatment-naïve patients with nasopharyngeal carcinoma NPC without metastasis will be enrolled for curative radiotherapy The participants will be randomly assigned to two groups The experimental group will receive online adaptive radiotherapy ART during the radiotherapy process with a smaller PTV margin while the control group will use original treatment plan during full-course radiotherapy with a PTV margin of 3 mm The study aims to compare the survival adverse events and quality of survival between the two groups with the primary endpoint being the locoregional recurrence-free survival rate The main objective is to determine the role of online ART in nasopharyngeal carcinoma elucidating its potential to alleviate radiation toxicity in patients while ensuring treatment efficacy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None