Preoperative Accelerated Partial Breast Irradiation (APBI) for Women With Stage I and Select IIA Breast Cancer (GCC 0919)
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|ClinicalTrials.gov Identifier: NCT01014715|
Recruitment Status : Active, not recruiting
First Posted : November 17, 2009
Last Update Posted : February 20, 2018
The purpose of this study is to examine the feasibility to deliver PBI before the lumpectomy is performed. By administering the PBI before the lumpectomy, a smaller volume of breast tissue may be exposed to radiation. The PBI method used in this study is 3D (three dimensional) conformal external beam irradiation. 3D-conformal external beam irradiation uses an x-ray beam to deliver the radiation dose. Approximately 3 weeks after completion of the PBI, the cancer will be surgically removed.
This study will learn about the good and bad effects of 3D-conformal external beam irradiation PBI when given before the cancer has been removed by lumpectomy. The study will also learn about the feelings women have about how their breast looks after PBI and surgery.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Other: Phase II - Preoperative Radiation followed by Lumpectomy.||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Preoperative Accelerated Partial Breast Irradiation (APBI) for Women With Stage I and Select IIA Breast Cancer|
|Actual Study Start Date :||September 2009|
|Actual Primary Completion Date :||December 2014|
|Estimated Study Completion Date :||December 2018|
Phase II-Preoperative Radiation followed by Lumpectomy
Other: Phase II - Preoperative Radiation followed by Lumpectomy.
Sequential investigative question. All procedures are standard of care
- The primary endpoint of this study is determination of the reproducibility of delivering preoperative APBI in Stage I and Stage IIA breast cancers. [ Time Frame: 5 years ]This will be done by using 3D-CRT by evaluating the prescription isodose curves, dose inhomogeneity, and coverage of the volume as defined by CT treatment planning to delineate the target volume.
- Evaluation of pathologic response, cosmetic results, of lumpectomy wound healing and the overall complication rate, ipsilateral breast recurrence rate [ Time Frame: 5 years ]These endpoints will be accomplished by utilizing the pathology report; the cosmesis will be judged by the patient, radiation oncologist and/or surgeon, at stated follow-up intervals; and the breast recurrence rate will be evaluated by disease status at routine patient follow-up appointments, including yearly mammography.
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): NCT01014715
|United States, Maryland|
|Baltimore, Maryland, United States, 21201|
|Central Maryland Oncology Center|
|Columbia, Maryland, United States, 21044|
|Baltimore Washington Medical Center|
|Glen Burnie, Maryland, United States, 21061|
|Principal Investigator:||Wendla Citron, MD||UMMC MSGCC Department of Radiation Oncology|