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Wide Excision Alone as Treatment for Ductal Carcinoma in Situ of The Breast

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Information provided by (Responsible Party):
Julia S. Wong, MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:
NCT00165256
First received: September 9, 2005
Last updated: May 2, 2013
Last verified: May 2013
History of Changes
  Purpose

The purpose of this study is to determine if wide excision (surgical removal) of the ductal carcinoma in situ of the breast (DCIS) alone is adequate therapy.


Condition Intervention Phase
Duct Carcinoma in Situ of the Breast
 Procedure: Wide Excision of DCIS
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Wide Excision Alone for DCIS-Grades 1 and 2

Resource links provided by NLM:

U.S. FDA Resources

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

Primary Outcome Measures:
  • To determine if patients with DCIS can be effectively treated with wide excision alone. [ Time Frame: TBD-survivorship ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To explore whether patients with grade 2 DCIS have a higher breast recurrence than patients with grade 1 DCIS. [ Time Frame: TBD-survivorship ] [ Designated as safety issue: No ]

Enrollment: 200
Study Start Date: May 1995
Estimated Study Completion Date: April 2016
Primary Completion Date: July 2002 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Wide Excision of DCIS
    Wide excision of DCIS and a minimum of 1cm histologically negatic breast tissue
Detailed Description:
  • Treatment consists of wide excision that will remove the area of DCIS and a minimum of 1cm histologically negative margin of breast tissue. A post-excision mammogram will be performed to verify complete excision of all calcifications.
  • Follow-up consists of physical examinations at least every 6 months by the surgeon or radiation oncologist. Mammograms of the affected breast will be obtained every 6 months for 5 years and then annually. Mammograms of the unaffected breast will be performed annually.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients must have high quality mammogram including magnification views of area containing suspicious calcifications.
  • The clinical extent of DCIS must be less than or equal to 2.5cm.
  • Grade 1 or 2 DCIS

Exclusion Criteria:

  • Patients with invasive carcinoma including microinvasive disease
  • Patients with nipple discharge
  • Patients with a history of prior malignancies other than squamous or basal cell carcinoma of the skin, or carcinoma in situ of the cervix.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00165256

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02115
Dana-Farber Cancer Center
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital
Beth Israel Deaconess Medical Center
Investigators
Principal Investigator: Julia Wong, MD Dana-Farber Cancer Institute
  More Information

No publications provided

Responsible Party: Julia S. Wong, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00165256     History of Changes
Other Study ID Numbers: 94-151
Study First Received: September 9, 2005
Last Updated: May 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:
Duct carcinoma in situ
DCIS
wide excision

Additional relevant MeSH terms:
Carcinoma
Carcinoma in Situ
Carcinoma, Intraductal, Noninfiltrating
Carcinoma, Ductal, Breast
Carcinoma, Ductal
Neoplasms, Ductal, Lobular, and Medullary
Breast Neoplasms
 Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013