A Phase II Study for Using Radiosurgery on Limited Metastases of Breast Cancer
N/A
N/A
Female
Breast Cancer, Metastatic
Trial Information
A Phase II Study for Using Radiosurgery on Limited Metastases of Breast Cancer
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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Determine efficacy using overall survival and disease-free survival
Outcome Time Frame:
from date of radiation treatment until the date of first documented progression or the date of death, assessed up to 120 months
Safety Issue:
No
Principal Investigator
Hong Zhang, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Rochester
Authority:
United States: Institutional Review Board
Study ID:
URCC 8700
NCT ID:
NCT00167414
Start Date:
December 2000
Completion Date:
January 2015
Related Keywords:
- Breast Cancer, Metastatic
- conformal radiotherapy
- Breast Neoplasms
- Neoplasm Metastasis
Name | Location |
|---|---|
| Department of Radiation Oncology: University of Rochester | Rochester, New York 14642 |
