Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

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.

Further Study Information

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 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

Trial Contact Information

Trial Lead Organizations/Sponsors

David C. Pratt Cancer Center at St. John's Mercy

Bethany G Sleckman, MD

Study Director

Kathy Baglan, MD		Ph: 314-251-6844
		Email: kathy.baglan@mercy.net

U.S.A.
Missouri
	St. Louis
	David C. Pratt Cancer Center at St. John's Mercy

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01347333
Information obtained from ClinicalTrials.gov on December 11, 2012

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