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Stereotactic Body Radiotherapy for Liver Tumors

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2015 by St. John's Mercy Research Institute, St. Louis.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01347333
First Posted: May 4, 2011
Last Update Posted: April 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
St. John's Mercy Research Institute, St. Louis
  Purpose
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 Intervention Phase
Liver Metastases Hepatocellular Carcinoma Intrahepatic Cholangiocarcinoma Radiation: Stereotactic body radiosurgery Radiation: Stereotactic Body Radiotherapy Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by St. John's Mercy Research Institute, St. Louis:

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


Estimated Enrollment: 50
Study Start Date: September 2008
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.
  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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
St. Louis, Missouri, United States, 63141
Sponsors and Collaborators
St. John's Mercy Research Institute, St. Louis
Investigators
Study Director: Bethany G Sleckman, MD Mercy Hospital St. Louis
  More Information

Responsible Party: St. John's Mercy Research Institute, St. Louis
ClinicalTrials.gov Identifier: NCT01347333     History of Changes
Other Study ID Numbers: 08-045
First Submitted: May 2, 2011
First Posted: May 4, 2011
Last Update Posted: April 13, 2016
Last Verified: November 2015

Keywords provided by St. John's Mercy Research Institute, St. Louis:
liver metastases
stereotactic radiosurgery

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