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Geometric Reproducibility of the Lumpectomy Cavity Using a Breast Cup Immobilization Device II

18 Years
Open (Enrolling)
Breast Cancer

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Trial Information

Geometric Reproducibility of the Lumpectomy Cavity Using a Breast Cup Immobilization Device II

Breast conserving therapy (BCT) has become the standard of care for treating early-stage
breast cancers based on six prospective randomized trials with 20 years of follow-up data
(Fisher). During lumpectomy, the surgeon removes the tumor and a surrounding rim of normal
tissue (margin), leaving surgical clips to help designate the resection bed. Radiation
treatment is directed at the whole breast for 5 1/2 weeks and is generally followed by a 1-2
week boost directed at the lumpectomy site plus a margin of normal breast tissue. The
benefit of adding the tumor bed boost, (TBB) has been shown in two studies to decrease local
failures [Romestaig; Bartelink].

Studies have evaluated the role of radiation following lumpectomy in very select groups
which have not been able to define a group who do not benefit from the addition of
radiotherapy. In the group of patients who received surgery alone, 85% of the breast
recurrences occurred in the tumor bed. Due to these two facts, radiotherapy directed only
at the tumor bed has been evaluated. Treating this smaller tumor volume has allowed higher
doses of radiation to be delivered safely shortening the treatment course from 6-7 weeks to
one week.

Inclusion Criteria:

1. The patient must consent to be in the study and have signed an IRB-approved consent

2. The patient must have a diagnosis of invasive or non-invasive breast cancer.

3. The patient must be planned for or have already had breast conservation surgery (i.e.

4 Age > 18. 5. There are at least two metal clips in the surgical cavity placed at the
time of surgery for guiding the radiation oncologist in delineating the target of
irradiation; or one radiographic clip placed at the time of stereotactic core needle
biopsy with the intact tumor.

6. Patients who have already been treated by radiation therapy and are being seen in
follow-up can also participate

Exclusion Criteria:

1. Male gender

2. Patients who cannot be set up comfortably in the prone position (e.g. physical

3. Tumor/lumpectomy site located in a portion of the breast that cannot be visualized
easily on the CT scan (e.g. superior portion of the upper outer quadrant).

4. Mastectomy was or is the recommended surgical approach.

Type of Study:


Study Design:

Time Perspective: Prospective

Outcome Measure:

Breast Cup Immobilization Device II (GCC 1047)

Outcome Description:

Assess the clinical feasibility,of using a breast cup immobilization device for prone breast irradiation in terms of both geometric and dosimetric accuracy

Outcome Time Frame:

One year

Safety Issue:


Principal Investigator

Steven Feigenberg, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Maryland


United States: Institutional Review Board

Study ID:




Start Date:

October 2012

Completion Date:

November 2013

Related Keywords:

  • Breast Cancer
  • Breast cancer
  • Lumpectomy
  • Breast Irradiation
  • Breast Neoplasms



Ummc Msgcc Baltimore, Maryland  21201