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


Phase 4
18 Years
N/A
Open (Enrolling)
Both
Liver Metastases, Hepatocellular Carcinoma, Intrahepatic Cholangiocarcinoma

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

local control rate

Outcome Description:

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.

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Bethany G Sleckman, MD

Investigator Role:

Study Director

Investigator Affiliation:

Mercy Hospital St. Louis

Authority:

United States: Institutional Review Board

Study ID:

08-045

NCT ID:

NCT01347333

Start Date:

September 2008

Completion Date:

September 2015

Related Keywords:

  • Liver Metastases
  • Hepatocellular Carcinoma
  • Intrahepatic Cholangiocarcinoma
  • liver metastases
  • stereotactic radiosurgery
  • Carcinoma
  • Liver Neoplasms
  • Neoplasm Metastasis
  • Cholangiocarcinoma
  • Carcinoma, Hepatocellular

Name

Location
St. John's Mercy Medical Center Saint Louis, Missouri  63141