Study for Using Radiosurgery on Limited Metastases of Breast Cancer



Status:Completed
Conditions:Breast Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any
Updated:1/7/2018
Start Date:December 2000
End Date:November 1, 2016

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A Phase II Study for Using Radiosurgery on Limited Metastases of Breast Cancer

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.

Before treatment begins, you will have a physical exam and blood tests. Physical evaluations
and blood tests will be done each week while you are receiving treatment, and at follow-up
visits. You will be seen for follow-up evaluations 4 weeks after treatment is completed, and
every three months thereafter. You will be asked to fill out a Quality of Life questionnaire,
which should take 5-10 minutes to complete. This will be done prior to treatment and at your
follow-up visits. You will receive high dose radiation therapy 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.

Inclusion Criteria:

- 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

Exclusion Criteria:

- 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.
We found this trial at
1
site
601 Elmwood Avenue
Rochester, New York 14642
?
mi
from
Rochester, NY
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