Study for Using Radiosurgery on Limited Metastases of Breast Cancer

Breast Cancer, Metastatic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00167414
• Other study ID #: URCC 8700
• Status: Completed
• Phase: N/A
• First received: September 9, 2005
• Last updated: December 8, 2017
• Start date: December 2000
• Est. completion date: November 1, 2016

Study information

• Verified date: December 2017
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: November 1, 2016
• Est. primary completion date: November 1, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer, Metastatic
• Breast Neoplasms

Intervention

Procedure:
• Hypofractionated Stereotactic Body Radiation Therapy
Hypofractionated Stereotactic Body Radiation Therapy

Radiation:
• Hypofractionated Stereotactic Body Radiation Therapy
Hypofractionated Stereotactic Body Radiation Therapy for treatment of limited metastases from breast cancer primary.

Locations

Country	Name	City	State
United States	Department of Radiation Oncology: University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Survival	The percent of patients that survived from date of enrollment until 2 year follow-up visit.	2 years
Primary	Overall Survival	The percent of patients that survived from date of enrollment until 4 year follow-up visit	4 years
Primary	Overall Survival	The percent of patients that survived from date of enrollment until 6 year follow-up visit	6 years
Secondary	Percent of Patients With Lesion Local Control	Lesion local failure was scored as an event if any treated lesion increased by greater than or equal to 20% using the Response Evaluation Criteria in Solid Tumors criteria or local failure was confirmed pathologically. Lesion control includes all participants that did not fall into the category of lesion failure.	6 years
Secondary	Number of Participants Who Experienced a Grade 4 or 5 Toxicity	Number of participants who experienced a grade 4 or 5 toxicity	6 years

External Links

•   Click here for more information about this study: Using Radiosurgery On Limited Metastases Of Breast Cancer