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

Phase 2
Open (Enrolling)
Breast Cancer, Metastatic

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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

- 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:


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:


Principal Investigator

Hong Zhang, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Rochester


United States: Institutional Review Board

Study ID:

URCC 8700



Start Date:

December 2000

Completion Date:

January 2015

Related Keywords:

  • Breast Cancer, Metastatic
  • conformal radiotherapy
  • Breast Neoplasms
  • Neoplasm Metastasis



Department of Radiation Oncology: University of Rochester Rochester, New York  14642