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Wide Excision Alone for DCIS-Grades 1 and 2


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Duct Carcinoma in Situ of the Breast

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Trial Information

Wide Excision Alone for DCIS-Grades 1 and 2


- 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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

To determine if patients with DCIS can be effectively treated with wide excision alone.

Outcome Time Frame:

TBD-survivorship

Safety Issue:

No

Principal Investigator

Julia Wong, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

94-151

NCT ID:

NCT00165256

Start Date:

May 1995

Completion Date:

April 2016

Related Keywords:

  • Duct Carcinoma in Situ of the Breast
  • Duct carcinoma in situ
  • DCIS
  • wide excision
  • Carcinoma
  • Carcinoma in Situ
  • Carcinoma, Intraductal, Noninfiltrating
  • Breast Neoplasms
  • Carcinoma, Ductal, Breast
  • Carcinoma, Ductal

Name

Location
Massachusetts General Hospital Boston, Massachusetts  02114-2617
Dana-Farber Cancer Center Boston, Massachusetts  02115