search
Back to results

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
University of Texas Southwestern Medical Center
About
Eligibility
Locations
Outcomes
Full info

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

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
October 19, 2007
Last Updated
February 11, 2019
Sponsor
University of Texas Southwestern Medical Center
search

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

Learn more about this trial

Stereotactic Radiosurgery for Patients With Hepatic Metastases.

We'll reach out to this number within 24 hrs