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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2010-00644 | Other Identifier | NCI/CTRP |
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No accrual
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RATIONALE: Breast-conserving surgery is a less invasive type of surgery for breast cancer and may have fewer side effects and improve recovery. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II clinical trial is studying how well breast-conserving surgery followed by radiation therapy works in treating patients with stage I or stage II breast cancer.
PRIMARY OBJECTIVES:
I. To determine ipsilateral breast tumor recurrence rates as well as tumor bed recurrence rates. Patients will be followed for a period of five years following completion of radiation to determine these rates.
II. To determine the cosmetic outcome resulting from breast conserving surgery and breast radiation.
SECONDARY OBJECTIVES:
I. To determine if there are patient factors which limit a patient's suitability to receive breast conserving therapy in the setting of multi-centric disease.
II. To determine patient satisfaction of breast conserving therapy as it pertains to their overall treatment experience as measured by a questionnaire.
III. To evaluate wound healing and overall complication rate after radiation as a component of breast conserving therapy.
OUTLINE:
Patients undergo breast-conserving surgery consisting of partial mastectomies followed by external beam breast radiation therapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed at 1 month, then every 3 months for 1 year, every 6 months for 1 year, and then annually for 5 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Patients undergo breast-conserving surgery consisting of partial mastectomies followed by external beam breast radiation therapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| external beam radiation therapy | Radiation | External beam breast radiation therapy 5 days a week for 5 weeks in the absence of disease progression or unacceptable toxicity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Ipsilateral breast tumor recurrence rates | Ipsilateral breast 6 months after diagnosis, bilateral annually for 5 years | 5 years after completion of radiation |
| To determine the cosmetic outcome resulting from breast conserving surgery and breast radiation | at 1 year after radiation |
| Measure | Description | Time Frame |
|---|---|---|
| To determine if there are patient factors which limit a patient's suitability to receive breast conserving therapy | 5 years after completion of radiation treatment | |
| Patient satisfaction with the procedure as determined by a questionnaire | at 1 year after radiation |
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| Name | Affiliation | Role |
|---|---|---|
| William Chen, MD | Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center | Cleveland | Ohio | 44106 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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| questionnaire administration | Other | Ancillary studies: The patient will complete the Cosmesis /QOL form (Appendix II) and the treating physician will complete the Cosmetic Guidelines (skin assessment) form for baseline data (Appendix I). |
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| therapeutic conventional surgery | Procedure | Patients will undergo excisional biopsy or needle localization removal of the tumor. Patients with margins < 2 mm undergo re-excision of the biopsy cavity. Surgical clips should be placed at the time of tylectomy to define the excision cavities. Ideally, clips are to be placed marking the superficial, deep, right, left, inferior, and superior dimensions of the tylectomy or re-excision cavities. |
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| To evaluate wound healing and overall complication rate after radiation | at one year after radiation |
| UH-Chagrin Highlands | Orange | Ohio | 44122 | United States |
| UH-Westlake | Westlake | Ohio | 44145 | United States |
| ID | Term |
|---|---|
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| D018270 | Carcinoma, Ductal, Breast |
| D018275 | Carcinoma, Lobular |
| D018567 | Breast Neoplasms, Male |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000071960 | Breast Carcinoma In Situ |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D044584 | Carcinoma, Ductal |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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