Back to resultsA Study For Using Radiosurgery On Limited Metastases
Primary Purpose
Neoplasms, Metastatic
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stereotactic Body Radiation Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Neoplasms, Metastatic
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years KPS ≥ 70 Palliative: Disease most likely to be life limiting, is definable, and treatable to a sterilizing dose according to protocol criteria. The size of the lesion must be such that it can be safely treated to sterilizing radiation doses according to the rules in the protocol Previously treated lesions are not eligible unless the prescribed dose can be safely delivered. Previously enrolled patients can be retreated to new lesions if they still meet protocol requirements. Informed consent must be obtained. Pregnancy test must be negative for women of child bearing potential. Out of state patients are eligible, if communication with the referring physicians is expected to be adequate to address the primary aim. The secondary aim (blood cytokines) is optional for out-of-state patients. Exclusion Criteria: Technical inability to achieve required dose based on safe dose constraints required for radiosurgery Women who are pregnant or nursing.. Failure to meet inclusion requirements Contraindications to radiation. Patient should not be eligible for primary disease specific radiosurgical protocols
Sites / Locations
- University of Rochester Department of Radiation Oncology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Stereotactic body radiation therapy
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Curatively Treated Patients With Progression-free Survival
Curatively treated patients were those with metastatic disease confined to the thorax and or with total metastases limited to five total lesions.
Percentage of Palliatively Treated Patients With Progression-free Survival
Palliatively treated patients were those with more extensive disease wherein lung metastasis were considered the most life limiting component of their disease.
Secondary Outcome Measures
Quality of Life and Correlation With Pro-apoptotic, Inflammatory, and Anabolic Cytokine Profiles
Correlation of data from QOL questionnaires and blood markers.
Analyze Impact of Disease Bulk and Number of Sites Involved.
Analysis or response and progression.
Full Information
NCT ID
NCT00178399
First Posted
September 12, 2005
Last Updated
October 9, 2018
Sponsor
University of Rochester
1. Study Identification
Unique Protocol Identification Number
NCT00178399
Brief Title
A Study For Using Radiosurgery On Limited Metastases
Official Title
A Pilot Study For Using Radiosurgery On Limited Metastases
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
April 2001 (Actual)
Primary Completion Date
March 15, 2007 (Actual)
Study Completion Date
March 15, 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The standard therapy in cases such as yours is surgery, radiation therapy, chemotherapy or hormonal therapy alone or in combination. The main purpose of this study is to evaluate whether radiosurgery alone affects your quality and length of life. A second purpose of this study is to determine if the levels of special types of protein (called cytokines) found in the blood are related to your quality of life during your course of treatment and follow-up.
Detailed Description
In this research study high dose stereotactic body radiation therapy will be directed at the site of metastasis. This treatment will be given once a day, 5 times a week (Monday through Friday) for one to four weeks depending on the location and size of the disease to be treated. Blood for the cytokine tests will be drawn before your therapy starts, weekly during therapy and at the follow-up visits as stated in the next paragraphs. Two to four tablespoons of blood will be removed each time.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Metastatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
128 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stereotactic body radiation therapy
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Stereotactic Body Radiation Therapy
Primary Outcome Measure Information:
Title
Percentage of Curatively Treated Patients With Progression-free Survival
Description
Curatively treated patients were those with metastatic disease confined to the thorax and or with total metastases limited to five total lesions.
Time Frame
24 months
Title
Percentage of Palliatively Treated Patients With Progression-free Survival
Description
Palliatively treated patients were those with more extensive disease wherein lung metastasis were considered the most life limiting component of their disease.
Time Frame
24 months
Secondary Outcome Measure Information:
Title
Quality of Life and Correlation With Pro-apoptotic, Inflammatory, and Anabolic Cytokine Profiles
Description
Correlation of data from QOL questionnaires and blood markers.
Time Frame
30 months from date of registration.
Title
Analyze Impact of Disease Bulk and Number of Sites Involved.
Description
Analysis or response and progression.
Time Frame
From the date of radiation therapy treatment to the date of first failure or last follow-up, assessed up to 10 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years
KPS ≥ 70
Palliative: Disease most likely to be life limiting, is definable, and treatable to a sterilizing dose according to protocol criteria.
The size of the lesion must be such that it can be safely treated to sterilizing radiation doses according to the rules in the protocol
Previously treated lesions are not eligible unless the prescribed dose can be safely delivered. Previously enrolled patients can be retreated to new lesions if they still meet protocol requirements.
Informed consent must be obtained.
Pregnancy test must be negative for women of child bearing potential.
Out of state patients are eligible, if communication with the referring physicians is expected to be adequate to address the primary aim. The secondary aim (blood cytokines) is optional for out-of-state patients.
Exclusion Criteria:
Technical inability to achieve required dose based on safe dose constraints required for radiosurgery
Women who are pregnant or nursing..
Failure to meet inclusion requirements
Contraindications to radiation.
Patient should not be eligible for primary disease specific radiosurgical protocols
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Milano, MD PhD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester Department of Radiation Oncology
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
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A Study For Using Radiosurgery On Limited Metastases
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