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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA043703 | U.S. NIH Grant/Contract | View source | |
| CASE2104 | Other Identifier | Case Comprehensive Cancer Center |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells.
PURPOSE: This clinical trial is studying how well partial breast radiation therapy works in treating women undergoing breast-conserving therapy for early stage breast cancer.
OBJECTIVES:
OUTLINE: Patients undergo partial breast irradiation comprising either MammoSite® brachytherapy twice daily for 5-10 days OR 3-dimensional conformal radiotherapy twice daily for 5-10 days.
After completion of study therapy, patients are followed periodically for up to 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MammoSite Brachytherapy | Experimental | Patients undergo partial breast irradiation comprising either MammoSite® brachytherapy twice daily for 5-10 days |
|
| 3-dimensional conformal radiotherapy | Experimental | 3-dimensional conformal radiotherapy twice daily for 5-10 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adjuvant therapy | Procedure | If chemotherapy is planned, it must begin no earlier than two weeks following completion of radiation. If chemotherapy is given first, a minimum of 2 weeks from the last cycle must elapse prior to the start of radiation. |
| Measure | Description | Time Frame |
|---|---|---|
| Cosmetic outcome as determined by an established scale employed by the radiation oncologist and the surgeon | 1 month after RT & Q3mos for one year | |
| Patient satisfaction with partial breast irradiation as measured by a questionnaire | Pre-treatment 1 mo 3 mo 6 mo 9 mo 1yr 5 yr | |
| Wound healing and overall complication rate after partial breast irradiation | 1 month after RT & Q3mos for one year | |
| Determination of which patients are best suited for each individual technique of partial breast irradiation | Patients will be followed for a period of five years following completion of radiation. | |
| Ipsilateral breast tumor recurrence rates and tumor bed recurrence rates | Ipsilateral breast 6 mos after dx, bilateral annually x 5 years |
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DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer, including the following histologic subtypes:
The following histologic subtypes are not allowed:
No extensive intraductal component by Harvard definition (i.e., more than 25% of the invasive tumor is DCIS or DCIS present in adjacent tissue)
Stage I or II disease (T1, N0; T1, N1a; T2, N0; or T2, N1a)
Lesion ≤ 3 cm
No more than 3 positive lymph nodes
Has undergone tylectomy (lumpectomy) and axillary lymph node sampling (axillary node dissection or sentinel node biopsy)
Unifocal breast cancer
No multicentric carcinoma (tumors in different quadrants of the breast or tumors separated by ≥ 4 cm)
No skin involvement of disease
No Paget's disease of the nipple
No distant metastatic disease
Hormone-receptor status not specified
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Janice Lyons, MD | Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lake/University Ireland Cancer Center | Cleveland | Ohio | 44060 | United States | ||
| Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center |
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| 3-dimensional conformal radiation therapy | Radiation | 3-dimensional conformal radiotherapy twice daily for 5-10 days. |
|
| brachytherapy | Radiation | Patients undergo partial breast irradiation comprising either MammoSite® brachytherapy twice daily for 5-10 days |
|
| Cleveland |
| Ohio |
| 44106-5065 |
| United States |
| UHHS Chagrin Highlands Medical Center | Cleveland | Ohio | 44122 | United States |
| UHHS Westlake Medical Center | Cleveland | Ohio | 44145 | United States |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D018270 | Carcinoma, Ductal, Breast |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D044584 | Carcinoma, Ductal |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
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| ID | Term |
|---|---|
| D017024 | Chemotherapy, Adjuvant |
| D020266 | Radiotherapy, Conformal |
| D001918 | Brachytherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
| D011881 | Radiotherapy, Computer-Assisted |
| D011878 | Radiotherapy |
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