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Stereotactic Radiosurgery in Treating Patients With Liver Metastases

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ClinicalTrials.gov Identifier: NCT00547677
Recruitment Status : Unknown
Verified January 2008 by National Cancer Institute (NCI).
Recruitment status was:  Active, not recruiting
First Posted : October 22, 2007
Last Update Posted : February 9, 2009
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Stereotactic radiosurgery may be able to send x-rays directly to the tumor and cause less damage to normal tissue.

PURPOSE: This phase I trial is studying the side effects and best dose of stereotactic radiosurgery in treating patients with liver metastases.

Condition or disease Intervention/treatment Phase
Metastatic Cancer Unspecified Adult Solid Tumor, Protocol Specific Radiation: stereotactic radiosurgery Phase 1

Detailed Description:


  • To determine the maximum tolerated dose of fractionated stereotactic radiosurgery in patients with hepatic metastases.
  • To determine the dose-limiting toxicity of stereotactic radiosurgery in these patients.
  • To assess the tumor response in these patients.

OUTLINE: This is a multicenter study.

Patients receive 3-5 fractions of stereotactic radiosurgery over 14 days in the absence of disease progression or unacceptable toxicity.

Cohorts of 9-13 patients receive escalating doses of stereotactic radiosurgery until 60 Gy is reached or the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which > 33% of patients experience dose-limiting toxicity.

After completion of study therapy, patients are followed at 6 weeks, every 3 months for 1 year, every 6 months for 2 years, and then annually for 2 years.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Allocation: Non-Randomized
Primary Purpose: Treatment
Official Title: A Phase I Trial of Stereotactic Radiosurgery for Patients With Hepatic Metastases (SBRT Liver)
Study Start Date : July 2004
Estimated Primary Completion Date : December 2007

Primary Outcome Measures :
  1. Maximum tolerated dose of stereotactic radiosurgery as assessed by NCI CTCAE v3.0

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


  • Histologically confirmed primary cancer

    • Stage IV primary disease with up to five liver metastases that are visualized on CT scan, MRI of the abdomen, or positron-emission tomography

      • No liver metastases secondary to germ cell tumor or hematologic malignancy
      • Other sites of metastases allowed
  • No malignant ascites
  • The cumulative total dose of radiotherapy to ≥ 2/3 of the liver and surrounding normal tissues, including the esophagus, stomach, and small bowel, must be ≤ 15 Gy
  • Percutaneous or laparoscopic biopsy of the metastasis and placement of 3-5 fiducials required if undergoing Cyberknife for treatment delivery


  • Karnofsky performance status 60-100%
  • Life expectancy ≥ 3 months
  • Albumin ≥ 3 g/dL
  • Alkaline phosphatase < 1.5 times upper limit of normal (ULN)
  • AST and ALT < 1.5 times ULN
  • Total bilirubin < 1.5 times ULN
  • Prothrombin time < 1.5 times ULN
  • Hemoglobin > 10 g/dL
  • Platelet count > 100,000/mm³
  • ANC > 1,000/mm³
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No history of diagnosed inflammatory bowel disease, such as ulcerative colitis or Crohn's disease
  • No active peptic ulcer disease
  • No hepato-renal syndrome


  • Prior systemic therapy allowed provided complete blood cell counts have recovered
  • No other concurrent antineoplastic treatment

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): NCT00547677

United States, Minnesota
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
United States, Texas
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, United States, 75390
Sponsors and Collaborators
Simmons Cancer Center
Study Chair: Robert D. Timmerman, MD Simmons Cancer Center

ClinicalTrials.gov Identifier: NCT00547677     History of Changes
Other Study ID Numbers: CDR0000571611
First Posted: October 22, 2007    Key Record Dates
Last Update Posted: February 9, 2009
Last Verified: January 2008

Keywords provided by National Cancer Institute (NCI):
liver metastases
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes