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A Phase I Trial of Stereotactic Radiosurgery for Patients With Hepatic Metastases (SBRT Liver)

Phase 1
18 Years
Open (Enrolling)
Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

A Phase I Trial of Stereotactic Radiosurgery for Patients With Hepatic Metastases (SBRT Liver)


- 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.

Inclusion Criteria


- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Primary Purpose: Treatment

Outcome Measure:

Maximum tolerated dose of stereotactic radiosurgery as assessed by NCI CTCAE v3.0

Safety Issue:


Principal Investigator

Robert D. Timmerman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Simmons Cancer Center


United States: Federal Government

Study ID:




Start Date:

July 2004

Completion Date:

Related Keywords:

  • Metastatic Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • liver metastases
  • unspecified adult solid tumor, protocol specific
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



University of Minnesota Cancer Center Minneapolis, Minnesota  55455
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas Dallas, Texas  75390