An interventional study of Phase II - Preoperative Radiation followed by Lumpectomy. in Breast Cancer, sponsored by University of Maryland, Baltimore. Completed at 3 sites in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-09-12.
Sponsored by University of Maryland, Baltimore · Not applicable, Interventional, and Prevention
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.
This study will evaluate the feasibility, cosmetic results, complication rates, and local control rate of 3D-CRT confined to the region of the lumpectomy cavity for patients with Stage I and IIa (less than or equal to 3 cm) carcinoma of the breast (non-lobular histology) treated with APBI using 3D-CRT before lumpectomy. For selected patients with Stage I and II breast carcinoma, 3D-CRT delivered to the primary tumor preoperatively is technically reproducible with acceptable complication rates. Cosmetic results after partial breast irradiation before lumpectomy will be comparable to that obtained after whole breast external beam radiation therapy. The local tumor control rate in the breast after partial breast irradiation therapy followed by lumpectomy will be comparable to that of conventional external beam radiation therapy, with less inconvenience and potentially less cost to the patient, given the selection criteria which minimize the risk of clinically significant multicentric or extensive residual carcinoma following lumpectomy.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 32 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →University of Maryland, Baltimore is the lead sponsor of 687 studies on the registry; 130 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 63 (70%) have results posted.
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Women who satisfy all of the following conditions are the only patients who will be eligible for this study:
Exclusion Criteria:
Men are not eligible for this study. Women with one or more of the following conditions also are ineligible for this study:
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.
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.
Time frame: 5 years
Evaluation of pathologic response, cosmetic results, of lumpectomy wound healing and the overall complication rate, ipsilateral breast recurrence rate
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.
Time frame: 5 years
This study is completed, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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University of Maryland, Baltimore