NCT05785845

Computed Tomography-Guided Stereotactic Adaptive Radiotherapy (CT-STAR) for the Treatment of Central and Ultra-Central Early-Stage Non-Small Cell Lung Cancer

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: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Early Stage Non-small Cell Lung Cancer
• Non-small Cell Lung Cancer

Interventions

Type	Name	Description
RADIATION	Computed tomography-guided stereotactic adaptive radiotherapy	Fractions will be delivered on consecutive business days.
DEVICE	ETHOS	ETHOS is a unique ring-gantry CT-guided linear accelerator notable for having an on-board cone beam CT (CBCT) imaging unit with improved definition and resolution to enable target and organ-at-risk contouring. It also has a dedicated artificial intelligence treatment planning system to allow for online adaptive radiotherapy.

Timeline

• Start date: 2023-04-10
• Primary completion: 2026-07-28
• Completion: 2026-07-28
• First posted: 2023-03-27
• Last updated: 2025-08-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study