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Tangential Radiation Therapy Without Axillary Dissection in Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00165243
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : June 7, 2017
Sponsor:
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Information provided by (Responsible Party):
Julia S. Wong, MD, Dana-Farber Cancer Institute

Brief Summary:
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 or disease Intervention/treatment Phase
Early-Stage Breast Cancer Procedure: Tangential radiation Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Tangential Radiation Therapy Without Axillary Dissection in Early-Stage Breast Cancer
Study Start Date : September 1998
Actual Primary Completion Date : January 2004
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer


Intervention Details:
  • Procedure: Tangential radiation
    Radiation given over 6 1/2 weeks


Primary Outcome Measures :
  1. To determine if patients with early-stage breast tumors can be effectively treated by tangential breast radiation. [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. To determine the safety of this treatment. [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00165243


Locations
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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
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Principal Investigator: Julia S. Wong, MD Dana-Farber Cancer Institute
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Responsible Party: Julia S. Wong, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00165243    
Other Study ID Numbers: 98-101
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: June 7, 2017
Last Verified: June 2017
Keywords provided by Julia S. Wong, MD, Dana-Farber Cancer Institute:
Axillary Dissection
Tangential Radiation
Breast Cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases