A Study For Using Radiosurgery On Limited Metastases

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00178399
Recruitment Status : Suspended (to analyze data of subjects already enrolled.)
First Posted : September 15, 2005
Last Update Posted : May 4, 2017
Information provided by (Responsible Party):
Michael Milano, MD,PhD, University of Rochester

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.

Condition or disease Intervention/treatment Phase
Neoplasms, Metastatic Procedure: Stereotactic Body Radiation Therapy Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 138 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study For Using Radiosurgery On Limited Metastases
Study Start Date : April 2001
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Arm Intervention/treatment
Experimental: Stereotactic body radiation therapy Procedure: Stereotactic Body Radiation Therapy

Primary Outcome Measures :
  1. 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.

Secondary Outcome Measures :
  1. 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.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00178399

United States, New York
University of Rochester Department of Radiation Oncology
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Principal Investigator: Michael Milano, MD PhD University of Rochester

Responsible Party: Michael Milano, MD,PhD, Associate Professor, University of Rochester Identifier: NCT00178399     History of Changes
Other Study ID Numbers: URCC 9700
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: May 4, 2017
Last Verified: May 2017