NCT04020276

OAR-Based, Dose Escalated SBRT With Real Time Adaptive MRI Guidance for Liver Metastases

A Phase I Study of OAR-Based, Dose Escalated SBRT With Real Time Adaptive MRI Guidance for Liver Metastases

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this trial is to identify a safe maximum tolerated dose level for MRI-guided Stereotactic Body Radiation Therapy (SBRT) treatment of bowel and liver metastases, respectively. Eligible participants will be on study for up to 12 months.

Detailed description

Stereotactic Body Radiation Therapy (SBRT) is a noninvasive local therapy with proven efficacy in a number of solid tumor types. The technique itself involves the precise administration of high biological equivalent dose radiation in order to maximize local control of discrete lesions. SBRT has been shown to be an effective therapy for both primary and metastatic liver tumors of multiple histologies. In metastatic liver disease from all primary tumor sites, patients treated with modern SBRT techniques generally enjoy very high levels of 1 and 2 year local control. However, CRC liver metastases have been shown to be particularly resistant to SBRT, and often are found to have significantly worse rates of control compared with other histologies. Recent studies indicate this might be due to the inherent radioresistance of the CRC histology. Despite this, there appears to be a relationship between increasing dose and improvement of local control, both within CRC and other tumor histologies. Higher SBRT dose was recently shown to improve local control in CRC pulmonary metastases, further corroborating the hypothesis of CRC as a radioresistant tumor. However, increasing dose delivery with SBRT has been limited based on the risk of toxicity to adjacent structures, and the ability to visualize them during treatment. This is particularly relevant in treating liver tumors, as tumor and small bowel movement can often make tumor targeting and organs-at-risk (OAR) avoidance especially difficult. MRI-guided SBRT for liver tumors is both safe and feasible and offers an as yet unprecedented opportunity to achieve the highest possible safe dose to liver tumors. Primary Objectives: * To determine the safety and tolerability of using increasing bowel dose constraints for MRI-guided SBRT treatment of metastatic liver deposits from all primary histologies except as outlined in the exclusion criteria. * To determine the safety and tolerability of using increasing volume-based liver constraints for MRI-guided SBRT treatment for metastatic liver deposits from all primary histologies except as outlined in the exclusion criteria. * To define maximally tolerated dose constraints for both liver and bowel based on DLT using real-time, adaptive, MRI-based treatment planning. Secondary Objectives: * To determine local recurrence rates at 1, and 2 years using MRI-guided SBRT with dose planning from escalation of OAR constraints. * To evaluate progression-free survival (PFS) and overall survival (OS) in this patient cohort. * To assess quality of life and patient reported outcomes at 2 months following MRI-guided SBRT.

Conditions

• Liver Metastases
• Stereotactic Body Radiation Therapy
• MRI-guided Treatment

Interventions

Type	Name	Description
RADIATION	SBRT	Participants will receive 5 fractions of radiation, which will be delivered 2-3 times per week. SBRT should be complete in a 1.5 to 2 week time frame. There should be a minimum of 12 hours between treatments.

Timeline

• Start date: 2019-11-04
• Primary completion: 2026-12-01
• Completion: 2028-12-01
• First posted: 2019-07-16
• Last updated: 2026-01-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study