Clinical Trial: Wide Excision Alone as Treatment for Ductal Carcinoma in Situ of The Breast
Study Status: Terminated
Recruit Status: Terminated
Study Type: Observational
Official Title: Wide Excision Alone for DCIS-Grades 1 and 2
Brief Summary: The purpose of this study is to determine if wide excision (surgical removal) alone is adequate treatment for small, grade 1 or 2 ductal carcinoma in situ (DCIS) of the breast.
Detailed Summary:
- Patients with DCIS are usually treated with the combination of breast-conserving surgery and radiation therapy or breast-conserving surgery alone. The purpose of this study is to evaluate whether localized low- or intermediate-grade DCIS, diagnosed with modern mammography and careful pathologic evaluation, could be treated with wide excision alone (omission of radiation therapy) and result in acceptably low local recurrence rates.
- 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.
Sponsor: Dana-Farber Cancer Institute
Current Primary Outcome: To determine if patients with DCIS can be effectively treated with wide excision alone. [ Time Frame: TBD-survivorship ]
Original Primary Outcome: To determine if patients with DCIS can be effectively treated with wide excision alone.
Current Secondary Outcome: To explore whether patients with grade 2 DCIS have a higher breast recurrence than patients with grade 1 DCIS. [ Time Frame: TBD-survivorship ]
Original Secondary Outcome: To explore whether patients with grade 2 DCIS have a higher breast recurrence than patients with grade 1 DCIS.
Information By: Dana-Farber Cancer Institute
Dates:
Date Received: September 9, 2005
Date Started: May 1995
Date Completion: April 2017
Last Updated: July 5, 2016
Last Verified: July 2016
