Stereotactic Radiosurgery for Patients With Hepatic Metastases.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Radiation: stereotactic radiosurgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Radiation: stereotactic radiosurgery|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum tolerated dose of stereotactic radiosurgery as assessed by NCI CTCAE v3.0 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver metastases, unspecified adult solid tumor, protocol specific