NCT00167414

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2000

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2000

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
11.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

January 5, 2018

Completed
Last Updated

January 5, 2018

Status Verified

December 1, 2017

Enrollment Period

15.9 years

First QC Date

September 9, 2005

Results QC Date

October 10, 2017

Last Update Submit

December 8, 2017

Conditions

Breast Cancer, Metastatic

Keywords

conformal radiotherapy

Outcome Measures

Primary Outcomes (3)

  • Overall Survival

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

    2 years

  • Overall Survival

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

    4 years

  • Overall Survival

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

    6 years

Secondary Outcomes (2)

  • Percent of Patients With Lesion Local Control

    6 years

  • Number of Participants Who Experienced a Grade 4 or 5 Toxicity

    6 years

Study Arms (1)

Hypofractionated Stereotactic Body Radiation Therapy

EXPERIMENTAL

Use of Hypofractionated Stereotactic Body Radiation Therapy for limited metastases with breast cancer primary.

Procedure: Hypofractionated Stereotactic Body Radiation TherapyRadiation: Hypofractionated Stereotactic Body Radiation Therapy

Interventions

Hypofractionated Stereotactic Body Radiation TherapyPROCEDURE

Hypofractionated Stereotactic Body Radiation Therapy

Hypofractionated Stereotactic Body Radiation Therapy

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • Contraindications to radiation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Radiation Oncology: University of Rochester

Rochester, New York, 14642, United States

Location

Related Links

MeSH Terms

Conditions

Breast NeoplasmsNeoplasm Metastasis

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplastic ProcessesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Hong Zhang
Organization
University of Rochester
hong_zhang@urmc.rochester.edu
585-341-6750

Study Officials

  • Hong Zhang, MD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor Department of Radiation Oncology

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

December 1, 2000

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

January 5, 2018

Results First Posted

January 5, 2018

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)