Breast Cup Immobilization Device II (GCC 1047) (BCID II)
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|ClinicalTrials.gov Identifier: NCT01704547|
Recruitment Status : Completed
First Posted : October 11, 2012
Last Update Posted : June 21, 2017
|Condition or disease|
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.
|Study Type :||Observational|
|Actual Enrollment :||25 participants|
|Official Title:||Geometric Reproducibility of the Lumpectomy Cavity Using a Breast Cup Immobilization Device II|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||March 2016|
- Breast Cup Immobilization Device II (GCC 1047) [ Time Frame: One year ]Assess the clinical feasibility,of using a breast cup immobilization device for prone breast irradiation in terms of both geometric and dosimetric accuracy
- Breast Cup Immobilization Device II (GCC 1047) [ Time Frame: One year ]1.Assess patient comfort while wearing the breast cup immobilization device and evaluate mock treatment plans for patients using the acquired CT images.
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 ClinicalTrials.gov identifier (NCT number): NCT01704547
|United States, Maryland|
|Baltimore, Maryland, United States, 21201|
|Principal Investigator:||Elizabeth Nichols, MD||University of Maryland, College Park|