NCT02683200

MRI-Guided Stereotactic Body Radiation Therapy in Treating Patients With Liver Metastases or Liver Cancer

Stereotactic Body Radiotherapy for Liver Metastases and Hepatocellular Carcinoma Utilizing an MRI-Guided Tri-60Co Teletherapy System

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This pilot clinical trial studies magnetic resonance imaging (MRI)-guided stereotactic body radiation therapy (SBRT) in treating patients with liver metastases or liver cancer. SBRT is a specialized radiation therapy that delivers a single, high dose of radiation directly to the tumor and may kill more tumor cells and cause less damage to normal tissue. Combining MRI with SBRT may help doctors to highlight the tissues surrounding the tumor better.

Detailed description

PRIMARY OBJECTIVES: I. To assess the feasibility of utilizing an MRI-guided tri-60Co teletherapy system for liver SBRT, as determined the treating radiation oncologist's ability to accurately visualize and align to the target lesion(s). II. To assess the feasibility of using a three versus five fraction scheme, for one versus multiple (i.e., =\< 5) target lesions. SECONDARY OBJECTIVES: I. To determine the tumor local control (LC), disease specific survival (DSS), and overall survival (OS). II. To gather biomarkers that may elucidate differential immunogenic responses from the three versus the five fraction SBRT regimens. OUTLINE: Patients undergo MRI-guided Tri-60Co teletherapy SBRT 3-5 fractions over 1-2 weeks. After completion of study treatment, patients are followed up at approximately 4-6 weeks, and then every 3 months for 2 years.

Conditions

• Adult Hepatocellular Carcinoma
• Metastatic Malignant Neoplasm in the Liver

Interventions

Type	Name	Description
RADIATION	Image-Guided Adaptive Radiation Therapy	Undergo MRI-guided Tri-60Co teletherapy SBRT
RADIATION	Stereotactic Body Radiation Therapy	Undergo MRI-guided Tri-60Co teletherapy SBRT

Timeline

• Start date: 2015-06-03
• Primary completion: 2022-01-01
• Completion: 2022-01-01
• First posted: 2016-02-17
• Last updated: 2023-02-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study