Skip to main content
OpenTrials
Completed

NCT Number: NCT00167414

Study for Using Radiosurgery on Limited Metastases of Breast Cancer

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.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Radiation Oncology: University of Rochester

Rochester, New York, 14642, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Hypofractionated Stereotactic Body Radiation Therapy

Procedure

Hypofractionated Stereotactic Body Radiation Therapy

Hypofractionated Stereotactic Body Radiation Therapy

Radiation

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

Primary outcomes

  1. Overall Survival

    Time frame: 2 years

    The percent of patients that survived from date of enrollment until 2 year follow-up visit.

  2. Overall Survival

    Time frame: 4 years

    The percent of patients that survived from date of enrollment until 4 year follow-up visit

  3. Overall Survival

    Time frame: 6 years

    The percent of patients that survived from date of enrollment until 6 year follow-up visit

Secondary outcomes

  1. Percent of Patients With Lesion Local Control

    Time frame: 6 years

    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.

  2. Number of Participants Who Experienced a Grade 4 or 5 Toxicity

    Time frame: 6 years

    Number of participants who experienced a grade 4 or 5 toxicity

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2016
Study completion
2016
First posted
Sep 14, 2005
Registry last updated
Jan 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.