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

Primary Purpose

Liver Cancer, Hepatocellular Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
individualized Stereotactic Body Radiation Therapy (SBRT)
Sponsored by
University of Michigan Rogel Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Michigan Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Liver cancer patients

Arm Description

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).

Outcomes

Primary Outcome Measures

The Percentage of Patients With Local Control at 1 Year Post Treatment
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

The Percentage of Patients Alive Without Progression at 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
The Number of Patients Who Experience Grade 4+ Hepatotoxicity
Grade 4 toxicities are life threatening toxicities that require urgent attention.
The Number of Patients That Experience Grade 4+ Gastrointestinal Bleeding
Grade 4 toxicities are life threatening toxicities that require urgent attention.

Full Information

First Posted
September 23, 2011
Last Updated
January 18, 2017
Sponsor
University of Michigan Rogel Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT01522937
Brief Title
A Study of Individualized Stereotactic Body Radiation Therapy (SBRT) for Intrahepatic Cancer
Official Title
A Phase II Study of Individualized Stereotactic Body Radiation Therapy (SBRT) for Intrahepatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
November 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Michigan Rogel Cancer Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cancer, Hepatocellular Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
94 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liver cancer patients
Arm Type
Experimental
Arm Description
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).
Intervention Type
Radiation
Intervention Name(s)
individualized Stereotactic Body Radiation Therapy (SBRT)
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Percentage of Patients With Local Control at 1 Year Post Treatment
Description
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.
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
The Percentage of Patients Alive Without Progression at 1 Year
Description
Progression is defined as a greater than or equal to 20% growth of a lesion from the smallest lesion measurement
Time Frame
1 Year
Title
The Percentage of Patients Alive at 1 Year
Time Frame
1 Year
Title
The Number of Patients Who Experience Grade 4+ Hepatotoxicity
Description
Grade 4 toxicities are life threatening toxicities that require urgent attention.
Time Frame
1 Year
Title
The Number of Patients That Experience Grade 4+ Gastrointestinal Bleeding
Description
Grade 4 toxicities are life threatening toxicities that require urgent attention.
Time Frame
1 Year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyle Cuneo, MD
Organizational Affiliation
University of Michigan Rogel Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Comprehensive Cancer Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109-5010
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
28796864
Citation
Feng M, Suresh K, Schipper MJ, Bazzi L, Ben-Josef E, Matuszak MM, Parikh ND, Welling TH, Normolle D, Ten Haken RK, Lawrence TS. Individualized Adaptive Stereotactic Body Radiotherapy for Liver Tumors in Patients at High Risk for Liver Damage: A Phase 2 Clinical Trial. JAMA Oncol. 2018 Jan 1;4(1):40-47. doi: 10.1001/jamaoncol.2017.2303.
Results Reference
derived

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

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