Clinical trial NCT00167414: Study for Using Radiosurgery on Limited Metastases of Breast Cancer
Official title: A Phase II Study for Using Radiosurgery on Limited Metastases of Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer, Metastatic
Keywords: conformal radiotherapy
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2005-09-14
Enrollment: 49
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall Survival
timeFrame: 2 years
measure: Overall Survival
timeFrame: 4 years
measure: Overall Survival
timeFrame: 6 years
Secondary outcomes:
measure: Percent of Patients With Lesion Local Control
timeFrame: 6 years
measure: Number of Participants Who Experienced a Grade 4 or 5 Toxicity
timeFrame: 6 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Department of Radiation Oncology: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Hong Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: