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:
University of Rochester
ClinicalTrials.gov Identifier:
NCT00178399
First received: September 12, 2005
Last updated: June 2, 2014
Last verified: June 2014
  Purpose

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 Intervention
Neoplasms, Metastatic
Procedure: Stereotactic Body Radiation Therapy

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Study For Using Radiosurgery On Limited Metastases

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • To determine the feasibility and potential utility of radiosurgery for limited metastatic disease, compared to historical controls. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Quality of life and correlation with pro-apoptotic, inflammatory, and anabolic cytokine profiles [ Designated as safety issue: No ]
  • Analyze impact of disease bulk and number of sites involved. [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: April 2001
Estimated Study Completion Date: April 2020
Estimated Primary Completion Date: April 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stereotactic body radiation therapy Procedure: Stereotactic Body Radiation Therapy

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00178399

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

No publications provided

Responsible Party: Michael Milano, MD PhD, University of Rochester
ClinicalTrials.gov Identifier: NCT00178399     History of Changes
Other Study ID Numbers: URCC 9700
Study First Received: September 12, 2005
Last Updated: June 2, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Neoplasms, Second Primary
Neoplasms

ClinicalTrials.gov processed this record on September 30, 2014