Stereotactic Radiosurgery for Patients With Hepatic Metastases.
Primary Purpose
Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
stereotactic radiosurgery
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Cancer focused on measuring liver metastases, unspecified adult solid tumor, protocol specific
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
Sites / Locations
- University of Minnesota Cancer Center
- Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Outcomes
Primary Outcome Measures
Maximum tolerated dose of stereotactic radiosurgery as assessed by NCI CTCAE v3.0
Secondary Outcome Measures
Full Information
NCT ID
NCT00547677
First Posted
October 19, 2007
Last Updated
February 11, 2019
Sponsor
University of Texas Southwestern Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00547677
Brief Title
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
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
July 2004 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Texas Southwestern Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific
Keywords
liver metastases, unspecified adult solid tumor, protocol specific
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Allocation
Non-Randomized
Enrollment
27 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Radiation
Intervention Name(s)
stereotactic radiosurgery
Primary Outcome Measure Information:
Title
Maximum tolerated dose of stereotactic radiosurgery as assessed by NCI CTCAE v3.0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert D. Timmerman, MD
Organizational Affiliation
Simmons Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Minnesota Cancer Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
12. IPD Sharing Statement
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Stereotactic Radiosurgery for Patients With Hepatic Metastases.
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