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Sponsors and Collaborators: |
UNC Lineberger Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00182728 |
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation during surgery may be an effective treatment for breast cancer.
PURPOSE: This phase II trial is studying how well radiation therapy works in treating older women who are undergoing surgery for invasive breast cancer.
Condition | Intervention | Phase |
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Breast Cancer |
Procedure: conventional surgery Procedure: neoadjuvant therapy Radiation: intraoperative radiation therapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized |
Official Title: | Partial Breast Treatment Using Single Dose Intraoperative Radiotherapy for Patients With Early Stage Breast Cancer - A Feasibility Study With Molecular Analysis of Tumors and Normal Breast Epithelial Tissue |
Estimated Enrollment: | 71 |
Study Start Date: | February 2003 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a non-randomized study.
Patients undergo intraoperative lymphatic mapping and sentinel lymphadenectomy OR standard level I, II axillary dissection to evaluate the lymph nodes followed by intraoperative breast ultrasonography to define the tumor target volume. Patients then undergo intraoperative single-dose partial breast radiotherapy followed by segmental mastectomy (i.e., lumpectomy) of the tumor. Patients with 1 or 2 tumor-involved surgical margins may undergo repeat segmental mastectomy. Patients with > 2 tumor-involved surgical margins undergo mastectomy. Patients determined to have a tumor size > 3 cm or an extensive intraductal component on final pathology evaluation undergo standard external beam radiotherapy after surgery.
After completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 71 patients will be accrued for this study within 2 to 3 years.
Ages Eligible for Study: | 48 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary invasive ductal carcinoma of the breast
Candidate for breast-conserving therapy, as determined by the surgical and radiation oncologist
No clinical or radiographic multifocal disease not amenable to single segmental mastectomy
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
Other prior malignancy allowed provided the following criteria are met:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, North Carolina | |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | |
Chapel Hill, North Carolina, United States, 27599-7295 |
Principal Investigator: | Carolyn Sartor, MD | UNC Lineberger Comprehensive Cancer Center |
Study ID Numbers: | CDR0000440120, UNC-LCCC-0218 |
Study First Received: | September 15, 2005 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00182728 History of Changes |
Health Authority: | United States: Federal Government |
invasive ductal breast carcinoma stage I breast cancer stage II breast cancer |
Skin Diseases Breast Neoplasms Carcinoma, Ductal, Breast Breast Diseases Carcinoma |
Neoplasms Neoplasms by Site Skin Diseases Breast Neoplasms Breast Diseases |