Study for Using Radiosurgery on Limited Metastases of Breast Cancer

Completed · Not applicable

Conditions studied: Breast Cancer, Metastatic

In brief

The purpose of this study is to evaluate whether radiosurgery, along with standard chemotherapy, immunotherapy (the treatment of cancer by modulating the immune system and immune response), or hormonal therapy, affects the quality and length of life. The standard therapy is surgery, radiation therapy, or chemotherapy alone or in any combination. A second purpose of this study is to determine if the levels of a special type of protein (called cytokines) found in the blood are related to the quality of life while on this treatment.

Key facts

Study ID

NCT00167414

Run by

University of Rochester

People needed

49

Starts

2000-12-01

Expected to finish

2016-11-01

Last updated by the study team

2018-01-05

Who can join

Age: any. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Age: no limit
• Karnofsky performance status (KPS) ≥ 70
• No more than 5 metastatic sites involving one or more different organs (liver, lung or bone).
• 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.
• Concurrent therapy is allowed and recommended. The chemotherapy protocol type and schedule are at the discretion of the medical oncologist.
• Informed consent must be obtained.
• Pregnancy test must be negative for women of child bearing potential

You may not qualify if…

• Inability of patient to be followed longitudinally as specified by protocol.
• Technical inability to achieve required dose based on safe dose constraints required for radiosurgery.
• Women who are pregnant or nursing.
• Failure to meet requirements in Inclusion Criteria
• Contraindications to radiation.

Where it is running

• Department of Radiation Oncology: University of Rochester — Rochester, New York, United States

Full record on ClinicalTrials.gov

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