Tangential Radiation Therapy Without Axillary Dissection in Breast Cancer - Full Text View

Sponsors and Collaborators:	Dana-Farber Cancer Institute Brigham and Women's Hospital Massachusetts General Hospital
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00165243

Purpose

The purpose of this study is to evaluate whether treatment to the axilla (area under the arm) can be safely minimized by omitting axillary surgery and full axillary radiation therapy and replacing it with radiation therapy to the breast and lower axilla.

Condition	Intervention	Phase
Early-Stage Breast Cancer	Procedure: Tangential radiation	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study
Official Title:	Tangential Radiation Therapy Without Axillary Dissection in Early-Stage Breast Cancer

Further study details as provided by Dana-Farber Cancer Institute:

Primary Outcome Measures:

To determine if patients with early-stage breast tumors can be effectively treated by tangential breast radiation. [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To determine the safety of this treatment. [ Time Frame: 5 years ] [ Designated as safety issue: Yes ]

Enrollment:	100
Study Start Date:	September 1998
Estimated Study Completion Date:	September 2008
Primary Completion Date:	January 2004 (Final data collection date for primary outcome measure)

Intervention Details:

Radiation given over 6 1/2 weeks

Detailed Description:

Patients will have undergone conservative breast surgery without axillary dissection prior to enrollment in this study.
Patients will receive radiation therapy to the breast, including the lowest axillary lymph nodes, over a period of 6 1/2 weeks.
No radiation will be specifically directed toward the upper axilla or supraclavicular lymph nodes.
Patients will also receive 5 years of tamoxifen or another type of hormone therapy determined by the medical oncologist.
Follow-up visits will occur every 6 months and mammograms every 12 months.

Eligibility

Ages Eligible for Study:	55 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients must have clinical stage I or II breast cancer, clinically uninvolved axillary nodes.
Patients must be 55 years or older.
Patients must undergo total excision of the primary invasive tumor
Final pathologic margin status must be negative
Only estrogen receptor (ER) or progesterone receptor (PR) positive tumors will be permitted

Exclusion Criteria:

Prior history of malignancy, except for non-melanoma skin cancers and carcinoma in situ fo the cervix

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00165243

Locations

United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

Dana-Farber Cancer Institute

Brigham and Women's Hospital

Massachusetts General Hospital

Investigators

Principal Investigator:

Julia S. Wong, MD

Dana-Farber Cancer Institute

More Information

Responsible Party:	Dana-Farber Cancer Institute/Brigham and Women's Hospital ( Julia S. Wong, MD )
Study ID Numbers:	98-101
Study First Received:	September 9, 2005
Last Updated:	December 22, 2007
ClinicalTrials.gov Identifier:	NCT00165243
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

Axillary Dissection
Tangential Radiation
Breast Cancer

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009