Clinical trial NCT00547677: Stereotactic Radiosurgery for Patients With Hepatic Metastases.
Official title: A Phase I Trial of Stereotactic Radiosurgery for Patients With Hepatic Metastases (SBRT Liver)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Metastatic Cancer
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: liver metastases
unspecified adult solid tumor, protocol specific
Lead sponsor: University of Texas Southwestern Medical Center
Sponsor class: OTHER
First posted: 2007-10-22
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Maximum tolerated dose of stereotactic radiosurgery as assessed by NCI CTCAE v3.0
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Cancer Center
state: Minnesota
city: Dallas
country: United States
facility: Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
state: Texas
Study officials:
affiliation: Simmons Cancer Center
name: Robert D. Timmerman, MD
role: STUDY_CHAIR
References: