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Study for Using Radiosurgery on Limited Metastases of Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hong Zhang, University of Rochester
ClinicalTrials.gov Identifier:
NCT00167414
First received: September 9, 2005
Last updated: October 15, 2012
Last verified: October 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Breast Cancer, Metastatic
 Procedure: Hypofractionated Stereotactic Body Radiation Therapy
Radiation: Hypofractionated Stereotactic Body Radiation Therapy
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Study for Using Radiosurgery on Limited Metastases of Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Determine efficacy using overall survival and disease-free survival [ Time Frame: from date of radiation treatment until the date of first documented progression or the date of death, assessed up to 120 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response (clinical, chemical [CA 27-29] and radiological), and quality of life correlation with pro-apoptotic, inflammatory, and anabolic cytokine profiles [ Time Frame: 30 months from initial registration on study ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: December 2000
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Hypofractionated Stereotactic Body Radiation Therapy
Use of Hypofractionated Stereotactic Body Radiation Therapy for limited metastases with breast cancer primary.
 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.

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

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00167414

Locations
United States, New York
Department of Radiation Oncology: University of Rochester
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
Principal Investigator: Hong Zhang, MD University of Rochester
  More Information

Additional Information:
Click here for more information about this study: Using Radiosurgery On Limited Metastases Of Breast Cancer  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Hong Zhang, Assistant Professor Department of Radiation Oncology, University of Rochester
ClinicalTrials.gov Identifier: NCT00167414     History of Changes
Other Study ID Numbers: URCC 8700
Study First Received: September 9, 2005
Last Updated: October 15, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
conformal radiotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasm Metastasis
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Neoplastic Processes
Pathologic Processes

ClinicalTrials.gov processed this record on May 21, 2013