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Sponsors and Collaborators: |
University of Pennsylvania National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00599989 |
RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells.
PURPOSE: This clinical trial is studying the side effects of partial breast radiation therapy and how well it works in treating women undergoing breast conservation therapy for early-stage breast cancer.
Condition | Intervention |
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Breast Cancer Long-Term Effects Secondary to Cancer Therapy in Adults Skin Reactions Secondary to Radiation Therapy |
Procedure: adjuvant therapy Procedure: conventional surgery Radiation: 3-dimensional conformal radiation therapy Radiation: brachytherapy Radiation: intracavitary balloon brachytherapy Radiation: proton beam radiation therapy |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Accelerated Partial Breast Irradiation |
Estimated Enrollment: | 100 |
Study Start Date: | January 2005 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
OUTLINE: Within 9 weeks after surgery, patients undergo accelerated partial breast irradiation (including conformal external-beam irradiation, interstitial brachytherapy, intracavitary brachytherapy, or proton beam irradiation) twice daily for 5 days (10 fractions).
After completion of study therapy, patients are followed every 3 to 6 months for at least 5 years and then annually thereafter.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Stage I-II invasive or intraductal breast cancer
Unifocal tumor ≤ 3.0 cm in size
No proven multicentric carcinoma in more than 1 quadrant or separated by 4 or more centimeters
Negative sentinel lymph node (SLN) or axillary lymph node dissection OR fewer than 4 positive nodes on adequate axillary lymph node dissection (i.e., 10 or more lymph nodes removed)
If a SLN is positive on hematoxylin and eosin (but not by immunohistochemistry alone), complete axillary lymph node dissection is required
Surgical clips placed in the operative bed OR ability to visualize operative bed on CT scan of the breast
No diffuse calcifications on diagnostic mammogram
PATIENT CHARACTERISTICS:
History of non-breast malignancies allowed provided patients have been disease free for 5 or more years prior to randomization and are deemed by their physician to be at low risk for recurrence
PRIOR CONCURRENT THERAPY:
United States, Pennsylvania | |
Abramson Cancer Center of the University of Pennsylvania | |
Philadelphia, Pennsylvania, United States, 19104-4283 |
Principal Investigator: | Lilie Lin, MD | University of Pennsylvania |
Study ID Numbers: | CDR0000581427, UPCC-08104, UPCC-IRB-801897 |
Study First Received: | January 11, 2008 |
Last Updated: | July 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00599989 History of Changes |
Health Authority: | United States: Federal Government |
long-term effects secondary to cancer therapy in adults skin reactions secondary to radiation therapy stage I breast cancer stage II breast cancer invasive lobular breast carcinoma with predominant in situ component invasive lobular breast carcinoma comedo ductal breast carcinoma ductal breast carcinoma in situ |
invasive ductal breast carcinoma medullary ductal breast carcinoma with lymphocytic infiltrate mucinous ductal breast carcinoma papillary ductal breast carcinoma tubular ductal breast carcinoma Paget disease of the breast with intraductal carcinoma Paget disease of the breast with invasive ductal carcinoma breast cancer in situ |
Skin Diseases Adjuvants, Immunologic Breast Neoplasms Carcinoma Carcinoma, Ductal Carcinoma, Lobular Carcinoma in Situ |
Osteitis Deformans Neoplasm Metastasis Carcinoma, Intraductal, Noninfiltrating Carcinoma, Ductal, Breast Paget Disease Breast Diseases |
Neoplastic Processes Neoplasms Pathologic Processes Neoplasms by Site |
Skin Diseases Neoplasm Metastasis Breast Neoplasms Breast Diseases |