Stereotactic Radiosurgery for Patients With Hepatic Metastases.

Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00547677
• Other study ID #: CDR0000571611
• Secondary ID: SCCC-062004-005
• Status: Completed
• Phase: Phase 1
• Start date: July 2004
• Est. completion date: December 2008

Study information

• Verified date: February 2019
• Source: University of Texas Southwestern Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 27
• Est. completion date: December 2008
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Metastatic Cancer
• Neoplasm Metastasis
• Unspecified Adult Solid Tumor, Protocol Specific

Intervention

Radiation:
• stereotactic radiosurgery

Locations

Country	Name	City	State
United States	Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas	Dallas	Texas
United States	University of Minnesota Cancer Center	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum tolerated dose of stereotactic radiosurgery as assessed by NCI CTCAE v3.0