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Stereotactic Body Radiotherapy for Liver Tumors

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ClinicalTrials.gov Identifier: NCT01347333
Recruitment Status : Completed
First Posted : May 4, 2011
Last Update Posted : January 26, 2018
Sponsor:
Information provided by (Responsible Party):
Kathy Baglan, MD, Mercy Research

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Liver Metastases Hepatocellular Carcinoma Intrahepatic Cholangiocarcinoma Radiation: Stereotactic body radiosurgery Radiation: Stereotactic Body Radiotherapy Not Applicable

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  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase IV Trial Evaluating the Use of Stereotactic Body Radiotherapy for the Treatment of Liver Metastases and Primary Liver Tumors
Study Start Date : September 2008
Actual Primary Completion Date : September 2016
Actual Study Completion Date : September 2016


Arm Intervention/treatment
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)
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)



Primary Outcome Measures :
  1. local control 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. Local control rate will be evaluated by imaging techniques, physical exam and biopsy, if applicable. If necessary, a PET/CT scan may be used to aid in the diagnoses of local tumor recurrence.


Secondary Outcome Measures :
  1. late complication rates [ Time Frame: 5 years ]
    Toxicities will be assessed using CTCAE grading criteria at specified timepoints.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01347333


Locations
United States, Missouri
St. John's Mercy Medical Center
Saint Louis, Missouri, United States, 63141
Sponsors and Collaborators
Mercy Research
Investigators
Study Director: Bethany G Sleckman, MD Mercy Hospital St. Louis

Responsible Party: Kathy Baglan, MD, Radiation Oncologist, Mercy Research
ClinicalTrials.gov Identifier: NCT01347333     History of Changes
Other Study ID Numbers: 08-045
First Posted: May 4, 2011    Key Record Dates
Last Update Posted: January 26, 2018
Last Verified: January 2018

Keywords provided by Kathy Baglan, MD, Mercy Research:
liver metastases
stereotactic radiotherapy

Additional relevant MeSH terms:
Neoplasm Metastasis
Carcinoma, Hepatocellular
Liver Neoplasms
Cholangiocarcinoma
Neoplastic Processes
Neoplasms
Pathologic Processes
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Liver Extracts
Hematinics