Stereotactic Body Radiotherapy for Liver Tumors

February 19, 2020 updated by: Kathy Baglan, MD, Mercy Research

Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy for the Treatment of Liver Metastases and Primary Liver Tumors

This study will evaluate the local control rate as well as acute and late toxicity rates of stereotactic body radiotherapy for the treatment of liver metastases and unresectable primary liver tumors such as hepatocellular carcinoma and intrahepatic cholangiocarcinoma.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a single site, non-randomized, prospective, phase IV trial.

Composed of 4 patient groups:

  1. Oligometastases (1-3) with aggregate tumor diameter < 6 cm
  2. Metastases from neuroendocrine tumors with functional endocrine syndromes
  3. Unresectable hepatocellular carcinoma (HCC)
  4. Unresectable intrahepatic cholangiocarcinoma (IHCC) Data collected will include patient demographics, pathology data, tumor stage, SBRT dose fractionation scheme, dose received by adjacent critical normal tissues, tumor recurrence data, and acute and late toxicities. Follow up data will be collected during the patient's standard office visits. The anticipated duration of this study is 5 years.

Study Type

Interventional

Enrollment (Actual)

23

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • St. John's Mercy Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient age >= 18 years
  • Zubrod performance status of 0-3
  • Oligometastases (1-3) with aggregate tumor diameter < 6 cm
  • Metastases from neuroendocrine tumors with functional endocrine syndromes for symptom palliation
  • Unresectable hepatocellular carcinoma (HCC)
  • Unresectable intrahepatic cholangiocarcinoma (IHCC)
  • Maximum tumor diameter < 6 cm
  • Adequate liver function:

Total bilirubin < 3 mg/dL Serum albumin > 2.5 g/dL Serum levels of liver enzymes < 3 times the upper limit of normal Normal PT and PTT unless patient is receiving anticoagulant medication

- Signed study-specific consent form

Exclusion Criteria:

  • Maximum tumor diameter > 6 cm
  • Prior radiotherapy to the liver
  • Pregnant or lactating women, due to potential exposure of the fetus to RT and unknown effects of RT on lactating females
  • Patients with psychiatric or addictive disorder that would preclude obtaining informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: liver metastases
Oligometastases (1-3) with aggregate tumor diameter < 6 cm Metastases from neuroendocrine tumors with functional endocrine syndromes
Radiation: Stereotactic body radiosurgery
36-60 Gy / 3 fractions (12-20 Gy per fraction) OR 45-50 Gy / 5 fractions (9-10 Gy per fraction)
OTHER: Primary Liver Tumors
Hepatocellular Carcinoma Intrahepatic Cholangiocarcinoma
Radiation: Stereotactic Body Radiotherapy
26-30 Gy / 1 fraction OR 36-45 Gy / 3 fractions (12-15 Gy per fraction) OR 40-50 Gy / 5 fractions (8-10 Gy per fraction)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local Tumor Recurrence Rate
Time Frame: 5 years
Primary endpoint will be local tumor recurrence rate. Local recurrence is defined as tumor recurrence within the planning target volume.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Late Complication Rates
Time Frame: 5 years
Toxicities will be assessed using CTCAE grading criteria at specified timepoints.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mercy Research

Investigators

  • Study Director: Bethany G Sleckman, MD, Mercy Hospital St. Louis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ACTUAL)

September 1, 2016

Study Completion (ACTUAL)

September 1, 2016

Study Registration Dates

First Submitted

May 2, 2011

First Submitted That Met QC Criteria

May 3, 2011

First Posted (ESTIMATE)

May 4, 2011

Study Record Updates

Last Update Posted (ACTUAL)

March 3, 2020

Last Update Submitted That Met QC Criteria

February 19, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 08-045

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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