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Completed

NCT Number: NCT01347333

Stereotactic Body Radiotherapy for Liver Tumors

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.

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Key information

Conditions

Liver Metastases Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Cholangiocarcinoma Digestive System Diseases Digestive System Neoplasms Hepatocellular Carcinoma Intrahepatic Cholangiocarcinoma Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. John's Mercy Medical Center

St Louis, Missouri, 63141, United States

About this study

This study is a single site, non-randomized, prospective, phase IV trial.

Composed of 4 patient groups:

  • Oligometastases (1-3) with aggregate tumor diameter < 6 cm
  • Metastases from neuroendocrine tumors with functional endocrine syndromes
  • Unresectable hepatocellular carcinoma (HCC)
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stereotactic body radiosurgery

Radiation

36-60 Gy / 3 fractions (12-20 Gy per fraction) OR 45-50 Gy / 5 fractions (9-10 Gy per fraction)

stereotactic body radiotherapy

Radiation

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 outcomes

  1. Local Tumor Recurrence 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.

Secondary outcomes

  1. Late Complication Rates

    Time frame: 5 years

    Toxicities will be assessed using CTCAE grading criteria at specified timepoints.

Sponsors and collaborators

Lead sponsor

Mercy Research

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2016
Study completion
2016
First posted
May 4, 2011
Registry last updated
Mar 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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