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NCT Number: NCT01522937

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

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).

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Key information

Conditions

Liver Cancer Digestive System Diseases Digestive System Neoplasms Hepatocellular Cancer Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-5010, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

individualized Stereotactic Body Radiation Therapy (SBRT)

Radiation

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 outcomes

  1. 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 outcomes

  1. 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

  2. The Percentage of Patients Alive at 1 Year

    Time frame: 1 Year

  3. The Number of Patients Who Experience Grade 4+ Hepatotoxicity

    Time frame: 1 Year

    Grade 4 toxicities are life threatening toxicities that require urgent attention.

  4. 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.

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2015
Study completion
2015
First posted
Feb 1, 2012
Registry last updated
Mar 9, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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