Stereotactic Body Radiotherapy for Liver Tumors

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
St. John's Mercy Research Institute, St. Louis
ClinicalTrials.gov Identifier:
NCT01347333
First received: May 2, 2011
Last updated: January 30, 2014
Last verified: January 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Toxicities will be assessed using CTCAE grading criteria at specified timepoints.


Estimated Enrollment: 50
Study Start Date: September 2008
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

Responsible Party: St. John's Mercy Research Institute, St. Louis
ClinicalTrials.gov Identifier: NCT01347333     History of Changes
Other Study ID Numbers: 08-045
Study First Received: May 2, 2011
Last Updated: January 30, 2014
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 23, 2014