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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Michigan Cancer Center
ClinicalTrials.gov Identifier:
NCT01522937
First received: September 23, 2011
Last updated: January 18, 2017
Last verified: January 2017
  Purpose
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).

Condition Intervention Phase
Liver Cancer
Hepatocellular Cancer
Radiation: individualized Stereotactic Body Radiation Therapy (SBRT)
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study of Individualized Stereotactic Body Radiation Therapy (SBRT) for Intrahepatic Cancer

Resource links provided by NLM:


Further study details as provided by University of Michigan Cancer Center:

Primary Outcome Measures:
  • The Percentage of Patients With Local Control at 1 Year Post Treatment [ Time Frame: 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:
  • The Percentage of Patients Alive Without Progression at 1 Year [ Time Frame: 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 [ Time Frame: 1 Year ]
  • The Number of Patients Who Experience Grade 4+ Hepatotoxicity [ Time Frame: 1 Year ]
    Grade 4 toxicities are life threatening toxicities that require urgent attention.

  • The Number of Patients That Experience Grade 4+ Gastrointestinal Bleeding [ Time Frame: 1 Year ]
    Grade 4 toxicities are life threatening toxicities that require urgent attention.


Enrollment: 94
Study Start Date: October 2009
Study Completion Date: November 2015
Primary Completion Date: November 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Liver cancer patients
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).
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.

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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01522937

Locations
United States, Michigan
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109-5010
Sponsors and Collaborators
University of Michigan Cancer Center
Investigators
Principal Investigator: Kyle Cuneo, MD University of Michigan Cancer Center
  More Information

Responsible Party: University of Michigan Cancer Center
ClinicalTrials.gov Identifier: NCT01522937     History of Changes
Other Study ID Numbers: UMCC 2009-053
HUM00029467 ( Other Identifier: University of Michigan Medical IRB )
Study First Received: September 23, 2011
Results First Received: January 18, 2017
Last Updated: January 18, 2017

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on March 28, 2017