Status:
COMPLETED
Study for Using Radiosurgery on Limited Metastases of Breast Cancer
Lead Sponsor:
University of Rochester
Conditions:
Breast Cancer, Metastatic
Eligibility:
FEMALE
Phase:
NA
Brief Summary
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 hormona...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
49 Patients enrolled
Trial Details
Trial ID
NCT00167414
Start Date
December 1 2000
End Date
November 1 2016
Last Update
January 5 2018
Active Locations (1)
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1
Department of Radiation Oncology: University of Rochester
Rochester, New York, United States, 14642