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A Study For Using Radiosurgery On Limited Metastases

This study has suspended participant recruitment.
(to analyze data of subjects already enrolled.)
Sponsor:
Information provided by (Responsible Party):
Michael Milano, MD,PhD, University of Rochester
ClinicalTrials.gov Identifier:
NCT00178399
First received: September 12, 2005
Last updated: May 1, 2017
Last verified: May 2017
September 12, 2005
May 1, 2017
April 2001
April 2020   (Final data collection date for primary outcome measure)
To determine the feasibility and potential utility of radiosurgery for limited metastatic disease, compared to historical controls. [ Time Frame: From the date of radiation therapy treatment to the date of first failure or date of death from any cause whichever came first, assessed up to 20 years. ]
Time to progression.
To determine the feasibility and potential utility of radiosurgery for limited metastatic disease, compared to historical controls.
Complete list of historical versions of study NCT00178399 on ClinicalTrials.gov Archive Site
  • Quality of life and correlation with pro-apoptotic, inflammatory, and anabolic cytokine profiles [ Time Frame: 30 months from date of registration. ]
    Correlation of data from QOL questionnaires and blood markers.
  • Analyze impact of disease bulk and number of sites involved. [ Time Frame: From the date of radiation therapy treatment to the date of first failure or last follow-up, assessed up to 10 years ]
    Analysis or response and progression.
  • Quality of life and correlation with pro-apoptotic, inflammatory, and anabolic cytokine profiles
  • Analyze impact of disease bulk and number of sites involved.
Not Provided
Not Provided
 
A Study For Using Radiosurgery On Limited Metastases
A Pilot Study For Using Radiosurgery On Limited Metastases
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.
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.
Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Neoplasms, Metastatic
Procedure: Stereotactic Body Radiation Therapy
Experimental: Stereotactic body radiation therapy
Intervention: Procedure: Stereotactic Body Radiation Therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
138
April 2020
April 2020   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00178399
URCC 9700
Yes
Not Provided
Not Provided
Not Provided
Michael Milano, MD,PhD, University of Rochester
University of Rochester
Not Provided
Principal Investigator: Michael Milano, MD PhD University of Rochester
University of Rochester
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP