Stereotactic Radiosurgery for Patients With Hepatic Metastases.

NCT ID: NCT00547677

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 27 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31
• Study Completion Date: 2008-12-31

Brief 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.

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.

Conditions

Metastatic Cancer; Unspecified Adult Solid Tumor, Protocol Specific

Study Design

• Allocation Method: NON_RANDOMIZED
• Primary Study Purpose: TREATMENT

Interventions

stereotactic radiosurgery

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Texas Southwestern Medical Center

OTHER

Sponsor Role: lead

Principal Investigators

Robert D. Timmerman, MD

Role: STUDY_CHAIR

Simmons Cancer Center

Locations

University of Minnesota Cancer Center

Minneapolis, Minnesota, United States

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, United States

Countries

United States

Other Identifiers

SCCC-062004-005

Identifier Type: -

Identifier Source: secondary_id

CDR0000571611

Identifier Type: -

Identifier Source: org_study_id