Targeted Intra-Operative Radiotherapy for the Management of Ductal Carcinoma In-Situ of the Breast (TARGIT-DCIS Trial): Use of Mammography and Breast MRI to Identify Candidates for IORT.

University of Southern California1 site in 1 country36 target enrollmentOctober 1, 2007

ConditionsBreast Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: University of Southern California
Enrollment: 36
Locations: 1
Primary Endpoint: Reoperation (Re-excision or Mastectomy) Rates Following WLE or IORT
Status: Terminated
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

We hypothesize that the combination of mammography and CE-MRI will improve the surgeon and radiologist's ability to define extent of disease prior to surgical resection, improve the odds of obtaining clear surgical margins, and increase the efficacy of IORT delivered immediately after initial surgical resection. In this investigation, we will determine whether or not patients deemed eligible for 'immediate" IORT based on mammography and CE-MRI can be successfully treated without the need for re-excision or additional radiotherapy due to inadequate surgical margins.

Registry

clinicaltrials.gov

Start Date

October 1, 2007

End Date

November 1, 2016

Last Updated

5 months ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

University of Southern California

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients with biopsy-proven DCIS, mammographic and CE-MRI evidence of DCIS measuring great then equal to 4cm, and a desire to receive breast conserving therapy, will be considered for participation in this study.
•Patient history, physical examination findings, and demographics (sex, age, height, weight, bra size, etc.) will be performed and documented.
•Inclusion Criteria for Initial Registration (all patients cohorts):
•All cohorts
•Signed informed consent and HIPAA documents
•Female sex
•Age great then equal to 40 years
•Localized ductal carcinoma in situ
•Clinically and/or histologically negative axillary lymph nodes
•No imaging or clinical findings suggestive of invasive carcinoma.

Exclusion Criteria

•Age less than 40
•DCIS associated with any evidence of microinvasion or invasive carcinoma on pre-operative imaging or core biopsy of the breast or axillary nodes.
•DCIS that is multicentric in the ipsilateral breast. Multicentricity will be defined at 2 or more lesions separated by more than 3 cm in the same breast.
•Non-epithelial breast malignancies such as sarcoma or lymphoma
•DCIS associated with diffuse suspicious or indeterminate microcalcifications
•Pregnancy or lactation
•Collagen vascular diseases, including Systemic lupus erythematosus, Systemic sclerosis (scleroderma), CREST Syndrome (calcinosis, Raynaud phenomenon, esophageal dysfunction, sclerodactyly, telangiectasia, and the presence of anticentromere antibodies), polymyositis, dermatomyositis with a CPK level above normal or with an active skin rash, inclusion-body myositis, or amyloidosis
•Serious psychiatric or addictive disorders

Outcomes

Primary Outcomes

Reoperation (Re-excision or Mastectomy) Rates Following WLE or IORT

Time Frame: 30 days

These are the rates of reoperation for re-excision or mastectomy following Wide Local Excision (WLE) or Intraoperative Radiation Therapy (IORT). The number of patients who required reoperation were reported below.