A Study of Individualized Stereotactic Body Radiation Therapy (SBRT) for Intrahepatic Cancer

Phase 2

Completed

• Conditions: Liver Cancer; Hepatocellular Cancer
• Interventions: Radiation: individualized Stereotactic Body Radiation Therapy (SBRT)

• Registration Number: NCT01522937
• Lead Sponsor: University of Michigan Rogel Cancer Center

Brief Summary

This is a Phase II trial to characterize the safety and efficacy of individualized stereotactic body radiation therapy (SRBT) for patients who have had previous liver treatment or who have primary hepatocellular carcinoma (HCC).

Detailed Description

The trial endpoints are toxicity, survival and progression-free survival. DCE-MRI and plasma biomarkers will also be collected to explore their use as tools for treatment individualization in future trials. During the current trial, an indicator of liver function, indocyanine green (ICG), will be used to identify during treatment patients who are at excess risk for radiation-induced liver disease (RILD) so that their radiation dose may be reduced. The model used for individualization will be updated as trial data accrue, so this is an adaptive trial of an individualized therapy. The planned accrual is seventy (70) evaluable patients over three years.

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2011-09-23
• Study First Submitted QC: 2012-01-27
• Study First Posted: 2012-02-01
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2017-01
• Results First Submitted: 2017-01-18
• Results First Submitted QC: 2017-01-18
• Last Update Submitted: 2017-01-18
• Results First Posted: 2017-03-09
• Last Update Posted: 2017-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 94

Inclusion Criteria

• over age 18
• life expectancy of at least 12 weeks
• Zubrod performance status of ≤2.
• biopsy proven hepatocellular carcinoma (HCC)
• liver metastases
• a discrete hepatic tumor(s) as defined by the Barcelona46 criteria - for cirrhotic patients, (1) 2 imaging studies showing hypervascular tumor > 2cm, or (2) single imaging study showing hypervascular tumor > 2cm with AFP ≥ 400 ng/mL
• a discrete hypervascular tumor present on two consecutive imaging studies (CT or MRI) with documented growth of > 1cm in diameter
• adequate organ function
• women and men not interested in pregnancy
• must be recovered from the effects of any prior surgery, radiation therapy, chemotherapy and the effects of Radiofrequency Ablation (RFA) or Transcatheter Arterial Chemo Embolization (TACE)
• minimum of 6 weeks following their last surgical procedure, radiation and chemotherapy.

Exclusion Criteria

• cannot be eligible for a curative liver resection
• uncontrolled ascites clinically evident on physical exam
• known allergy to IC-Green
• known allergy to intravenous iodinated contrast agents
• patients with poor venous access
• patients with metastatic cancer with normal liver function who have not undergone previous liver directed therapy and a single tumor < 6 cm in size.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Liver cancer patients	individualized Stereotactic Body Radiation Therapy (SBRT)	The aim of this study is to determine the safety and effectiveness of individualized Stereotactic Body Radiation Therapy (SBRT) in patients who either (1) have had previous liver treatments, and/or (2) have primary hepatocellular carcinoma (HCC).

Primary Outcome Measures

Name	Time	Method
The Percentage of Patients With Local Control at 1 Year Post Treatment	1 Year	For this study, local control is defined as the lack of progressive local disease following CR (Complete Response) or PR (Partial Response), or lack of progressive local disease in patients with non-evaluable disease, who have no progressive elevation in serum tumor markers.

Secondary Outcome Measures

Name	Time	Method
The Percentage of Patients Alive Without Progression at 1 Year	1 Year	Progression is defined as a greater than or equal to 20% growth of a lesion from the smallest lesion measurement
The Percentage of Patients Alive at 1 Year	1 Year
The Number of Patients Who Experience Grade 4+ Hepatotoxicity	1 Year	Grade 4 toxicities are life threatening toxicities that require urgent attention.
The Number of Patients That Experience Grade 4+ Gastrointestinal Bleeding	1 Year	Grade 4 toxicities are life threatening toxicities that require urgent attention.

Trial Locations

Locations (1)

University of Michigan Comprehensive Cancer Center; 🇺🇸 Ann Arbor, Michigan, United States