A Phase I Trial of Stereotactic Radiosurgery for Patients With Hepatic Metastases (SBRT Liver)
18 Years
N/A
Both
Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
A Phase I Trial of Stereotactic Radiosurgery for Patients With Hepatic Metastases (SBRT Liver)
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Primary Purpose: Treatment
Outcome Measure:
Maximum tolerated dose of stereotactic radiosurgery as assessed by NCI CTCAE v3.0
Safety Issue:
Yes
Principal Investigator
Robert D. Timmerman, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Simmons Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000571611
NCT ID:
NCT00547677
Start Date:
July 2004
Completion Date:
Related Keywords:
- Metastatic Cancer
- Unspecified Adult Solid Tumor, Protocol Specific
- liver metastases
- unspecified adult solid tumor, protocol specific
- Neoplasm Metastasis
- Neoplasms
- Neoplasms, Second Primary
Name | Location |
|---|---|
| University of Minnesota Cancer Center | Minneapolis, Minnesota 55455 |
| Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas | Dallas, Texas 75390 |
