Stereotactic Radiosurgery in Treating Patients With Liver Metastases

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2008 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00547677
First received: October 19, 2007
Last updated: February 6, 2009
Last verified: January 2008

October 19, 2007
February 6, 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 [ Designated as safety issue: Yes ]
Maximum tolerated dose of stereotactic radiosurgery as assessed by NCI CTCAE v3.0
Complete list of historical versions of study NCT00547677 on ClinicalTrials.gov 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.

OBJECTIVES:

  • 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.

Interventional
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
27
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December 2007   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • 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

PATIENT CHARACTERISTICS:

  • 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 CONCURRENT THERAPY:

  • Prior systemic therapy allowed provided complete blood cell counts have recovered
  • No other concurrent antineoplastic treatment
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00547677
CDR0000571611, SCCC-062004-005
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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