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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

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 14, 2005
Last Update Posted Date June 7, 2017
Study Start Date  ICMJE September 1998
Actual Primary Completion Date January 2004   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 22, 2007)
To determine if patients with early-stage breast tumors can be effectively treated by tangential breast radiation. [ Time Frame: 5 years ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
To determine if patients with early-stage breast tumors can be effectively treated by tangential breast radiation.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 22, 2007)
To determine the safety of this treatment. [ Time Frame: 5 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 9, 2005)
To determine the safety of this treatment.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tangential Radiation Therapy Without Axillary Dissection in Breast Cancer
Official Title  ICMJE Tangential Radiation Therapy Without Axillary Dissection in Early-Stage Breast Cancer
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.
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Early-Stage Breast Cancer
Intervention  ICMJE Procedure: Tangential radiation
Radiation given over 6 1/2 weeks
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 9, 2005)
100
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2016
Actual Primary Completion Date January 2004   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00165243
Other Study ID Numbers  ICMJE 98-101
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Julia S. Wong, MD, Dana-Farber Cancer Institute
Study Sponsor  ICMJE Dana-Farber Cancer Institute
Collaborators  ICMJE
  • Brigham and Women's Hospital
  • Massachusetts General Hospital
Investigators  ICMJE
Principal Investigator: Julia S. Wong, MD Dana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date June 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP