Targeted Intra-Operative Radiotherapy for the Management of Ductal Carcinoma In-Situ of the Breast

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00556907
Recruitment Status : Terminated (Lack of Funding)
First Posted : November 12, 2007
Last Update Posted : July 11, 2017
Information provided by (Responsible Party):
University of Southern California

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Radiation: Intraoperative radiotherapy Device: Intraoperative radiotherapy Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : October 2007
Actual Primary Completion Date : March 2015
Actual Study Completion Date : November 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mammography

Arm Intervention/treatment
Patients will receive IORT
Radiation: Intraoperative radiotherapy
20Gy to surface of tumor bed and 5Gy at depth of 1cm from surface of tumor bed
Other Name: Intrabeam Photon Radiosurgery System and Applicators

Device: Intraoperative radiotherapy
20gy to tumor bed, 5gy at depth of 1cm from surface of tumor bed
Other Name: Intrabeam Photon Radiosurgery

Primary Outcome Measures :
  1. Feasibility. The primary efficacy endpoint will be reoperation (re-excision or mastectomy) rates following WLE or IORT [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. Safety endpoints: The overall serious adverse event rate will be assessed for all patients at stated follow-up periods. Complications associated with each of the following setting will be documented and reported separately [ Time Frame: 2 years ]

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Cohort 1 (Immediate IORT group)

  • Localized DCIS measuring less then equal to 4 cm on preoperative imaging.
  • Cohort 2 (Delayed IORT group)
  • Localized DCIS measuring less then equal to4 cm or less on surgical pathology
  • Delayed IORT could be performed for the explicit purpose of administering IORT or performed following re-excision of a previously operated breast to achieve clear surgical margins.
  • This cohort includes patients who were excluded from immediate IORT based on pre-operative imaging suggesting ineligibility for immediate IORT, but who are subsequently found to meet histological criteria (localized DCIS less then equal to 4 cm and no invasive cancer) for IORT based on surgical pathology.
  • Unifocal microinvasive (T1mic or invasive focus less then equal to 1mm in maximal diameter) is allowed following initial WLE if surgical pathology margins were less then equal to2 mm for both the invasive and non-invasive components.
  • Delayed IORT must be performed within 3 months of initial WLE.
  • Cohort 3 Subjects who received IORT at the time of initial WLE but whose surgical pathology showed them to be unsuitable candidates for IORT alone on the basis of:
  • DCIS measuring greater than 5 cm on surgical pathology.
  • T1a (less than 1 mm) or larger invasive carcinoma associated with extensive DCIS.
  • Surgical margins width less than1 mm.

Exclusion Criteria:

  • Male sex
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00556907

United States, California
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States, 90033
Sponsors and Collaborators
University of Southern California
Principal Investigator: Heather Macdonald, MD University of Southern California

Responsible Party: University of Southern California Identifier: NCT00556907     History of Changes
Other Study ID Numbers: 1B-06-9
First Posted: November 12, 2007    Key Record Dates
Last Update Posted: July 11, 2017
Last Verified: July 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by University of Southern California:
To evaluate Preoperative mammagraphy and MRI to select candiates with DCIS for IORT

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