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: September 30, 2013
Last verified: September 2013
  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:


Further study details as provided by University of Rochester:

Primary Outcome Measures:
  • Overall survival [ Time Frame: From the date of radiation therapy treatment to the date of first failure or last follow-up, assessed up to 10 years ] [ 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 date of registration ] [ Designated as safety issue: No ]

Estimated Enrollment: 80
Study Start Date: December 2000
Estimated Study Completion Date: October 2021
Estimated Primary Completion Date: October 2021 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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: September 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Rochester:
conformal radiotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014