Tangential Radiation Therapy Without Axillary Dissection in Breast Cancer - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

September 9, 2005

Last Updated Date

December 22, 2007

Start Date ^†

September 1998

Current 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 ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00165243 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

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

Original Secondary Outcome Measures ^†

Same as current

Descriptive Information

Brief Title ^†

Tangential Radiation Therapy Without Axillary Dissection in Breast Cancer

Official Title ^†

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 Phase

Phase II

Study Type ^†

Interventional

Study Design ^†

Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Efficacy Study

Condition ^†

Early-Stage Breast Cancer

Intervention ^†

Procedure: Tangential radiation

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Active, not recruiting

Enrollment ^†

100

Estimated Completion Date

September 2008

Primary Completion Date

January 2004 (final data collection date for primary outcome measure)

Eligibility 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

Gender

Both

Ages

55 Years and older

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00165243

Responsible Party

Julia S. Wong, MD, Dana-Farber Cancer Institute/Brigham and Women's Hospital

Secondary IDs ^††

Study Sponsor ^†

Dana-Farber Cancer Institute

Collaborators ^††

Brigham and Women's Hospital
Massachusetts General Hospital

Investigators ^†

Principal Investigator:

Julia S. Wong, MD

Dana-Farber Cancer Institute

Information Provided By

Dana-Farber Cancer Institute

Verification Date

December 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.