This trial is active, not recruiting.

Conditions metastatic cancer, unspecified adult solid tumor, protocol specific
Treatment stereotactic radiosurgery
Phase phase 1
Sponsor Simmons Cancer Center
Start date July 2004
End date December 2007
Trial size 27 participants
Trial identifier NCT00547677, CDR0000571611, SCCC-062004-005


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Primary purpose treatment

Primary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title A Phase I Trial of Stereotactic Radiosurgery for Patients With Hepatic Metastases (SBRT Liver)
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2009.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).