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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
History of Changes
  Purpose

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 Intervention Phase
Metastatic Cancer
Unspecified Adult Solid Tumor, Protocol Specific
 Radiation: stereotactic radiosurgery
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Primary Purpose: Treatment
Official Title: A Phase I Trial of Stereotactic Radiosurgery for Patients With Hepatic Metastases (SBRT Liver)

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Maximum tolerated dose of stereotactic radiosurgery as assessed by NCI CTCAE v3.0 [ Designated as safety issue: Yes ]

Estimated Enrollment: 27
Study Start Date: July 2004
Estimated Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00547677

Locations
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
Investigators
Study Chair: Robert D. Timmerman, MD Simmons Cancer Center
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

ClinicalTrials.gov Identifier: NCT00547677     History of Changes
Other Study ID Numbers: CDR0000571611, SCCC-062004-005
Study First Received: October 19, 2007
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

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

Additional relevant MeSH terms:
Neoplasm Metastasis
Neoplasms
Neoplasms, Second Primary
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on May 19, 2013