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Stereotactic Radiosurgery in Treating Patients With Liver Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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)

October 19, 2007
October 22, 2007
February 9, 2009
July 2004
December 2007   (Final data collection date for primary outcome measure)
Maximum tolerated dose of stereotactic radiosurgery as assessed by NCI CTCAE v3.0
Same as current
Complete list of historical versions of study NCT00547677 on Archive Site
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Stereotactic Radiosurgery in Treating Patients With Liver Metastases
A Phase I Trial of Stereotactic Radiosurgery for Patients With Hepatic Metastases (SBRT Liver)

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.


  • 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.

Phase 1
Allocation: Non-Randomized
Primary Purpose: Treatment
  • Metastatic Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
Radiation: stereotactic radiosurgery
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
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December 2007   (Final data collection date for primary outcome measure)


  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
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Simmons Cancer Center
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Study Chair: Robert D. Timmerman, MD Simmons Cancer Center
National Cancer Institute (NCI)
January 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP