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

Liver Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01522937
• Other study ID #: UMCC 2009-053
• Secondary ID: HUM00029467
• Status: Active, not recruiting
• Phase: Phase 2
• First received: September 23, 2011
• Last updated: December 4, 2015
• Start date: October 2009
• Est. completion date: November 2016

Study information

• Verified date: December 2015
• Source: University of Michigan Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: November 2016
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 iodidated 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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatocellular Cancer
• Liver Cancer
• Liver Neoplasms

Intervention

Radiation:
• individualized Stereotactic Body Radiation Therapy (SBRT)
The individualized SBRT involves two treatment phases. The first phase of treatment involves receiving three fractions of SBRT, followed by a 1-month break and assessment of liver function with a blood test - Indocyanine Green (IC-Green). The second phase of treatment involves receiving two more fractions of SBRT, whose doses are adjusted to account for tolerance of the first phase of treatment.

Locations

Country	Name	City	State
United States	University of Michigan Comprehensive Cancer Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor measure rates	Tumor size will be measured every 2 months following treatment to assess for shrinkage, stability of size, or increasing size. Adverse events will also be monitored every 2 months to assess for safety.	6 months	Yes
Secondary	assessment of plasma biomarkers for liver function	Collect data on plasma biomarkers of liver function to plan further enhancements to individualized SBRT	6 months	Yes