NCT02950792

MRI Adaptive Replanning Using ViewRay

A Study of Adaptive Radiotherapy Using ViewRay MRI Based Imaging in Locally Advanced Non-Small Cell Lung Cancer (NSCLC)

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Current dose escalation regimens with and without chemotherapy have failed to achieve improved local control and overall survival over standard of care therapy to date. Difficulties with dose escalation have been largely due to dose limiting toxicities of surrounding normal organs, in particular to the normal lung parenchyma, and esophagus. Real time, online adaptive planning using magnetic resonance imaging (MRI) could achieve significant volume reduction of primary lung disease over the course of therapy, thereby reducing dose to normal structures, and providing a mechanism in which to dose escalate safely, and more effectively with accurate target delineation. The investigators hypothesize that MRI based adaptive planning will provide a novel method to dose escalate safely with acceptable organ at risk doses. In addition, further improvements in radiotherapy targeting accuracy, normal tissue avoidance, and conformality of target-tissue coverage will be achieved through the use of 4D real-time tracking which is derived by deformably registering daily MR and planning MR (MRsim) and Computed Tomography Simulator (CTsim) with advanced non-rigid image-registration tools.

Detailed description

This study is a single-arm phase II study of adaptive radiotherapy using ViewRay MRI based imaging in locally Advanced non-small cell lung cancer patients. Randomization is not applicable.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DEVICE	ViewRay MRI	ViewRay Magnetic Resonance Imaging
RADIATION	Stereotactic Body Radiation Therapy Boost	In the (week 5), all patients will have a week 5 MRI and Four-dimensional computed tomography (4D CT) for purposes of planning Phase II boost. Gross tumors \< 5 cm will receive a MR-based adaptive replanning Stereo boost of 80 Gy - 90 Gy (20 Gy-30 Gy in 5 fractions). Gross tumors \< 5cm will receive an MR-based adaptive replan fractionated boost to 74 Gy at 2.4 Gy/day. Individualized radiation therapy prescription to primary tumor will maintain organs at risk (OAR) constraints to lung including mean lung dose (MLD) \< 20 Gy with V20 \< 37%. Simultaneously, MRI-based adaptive replanning boost of 12 Gy in 5 fractions (2.4 Gy/day) will be given to gross lymph nodes. Final doses prescribed will be limited by doses to all OARs.

Timeline

• Start date: 2017-08-01
• Primary completion: 2017-08-08
• Completion: 2017-08-08
• First posted: 2016-11-01
• Last updated: 2017-08-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study