Ignite Creation Date:
2024-05-06 @ 6:48 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05785845
Status:
RECRUITING
Last Update Posted:
2024-07-03
First Post:
2023-03-14
Brief Title:
Computed Tomography-Guided Stereotactic Adaptive Radiotherapy CT-STAR for the Treatment of Central and Ultra-Central Early-Stage Non-Small Cell Lung Cancer
Sponsor:
Washington University School of Medicine
Organization:
Washington University School of Medicine
Study Overview
Official Title:
A Phase I Trial of Computed Tomography-Guided Stereotactic Adaptive Radiotherapy CT-STAR for the Treatment of Central and Ultra-Central Early-Stage Non-Small Cell Lung Cancer
Status:
RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
This study will evaluate the impact of CT-guided adaptive stereotactic radiotherapy CT-STAR to central and ultra-central early-stage non-small cell lung cancers on grade 3 or greater toxicity Online adaptive radiation therapy was until recently only done clinically on an integrated MRI-guided system but recently Varian Medical Systems has created a CT-guided radiotherapy machine capable of online adaptive radiotherapy ETHOS The vast majority of stereotactic body radiotherapy SBRT for early-stage lung cancers is performed on a CT-guided machine rather than an MRI-guided machine necessitating the evaluation of adaptive radiotherapy using ETHOS in this population Historically the non-adaptive stereotactic treatment of central and ultra-central thoracic disease has been associated with unacceptable rates of grade 3 toxicity This has resulted in widespread adoption of a hypofractionated less ablative 8-15 day treatment courses with a baseline one-year grade 3 toxicity rate of 20 Use of CT-STAR with daily CT-guided plan adaptation to carefully spare adjacent organs-at-risk OAR in this setting may enable safe delivery of a shorter 5 fraction and more ablative radiotherapy course
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None