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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA015083 | U.S. NIH Grant/Contract | View source | |
| MCS066 | Other Identifier | Mayo Clinic Cancer Center | |
| 1681-02 | Other Identifier | Mayo Clinic IRB |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy during and after surgery may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying the side effects of giving radiation therapy during and after lumpectomy and to see how well it works in treating women with stage I or stage II breast cancer.
OBJECTIVES:
OUTLINE: Patients undergo standard lumpectomy. Patients with negative lymph nodes undergo intraoperative electron radiotherapy to the tumor bed. Beginning 2-8 weeks after surgery, patients undergo whole breast external beam radiotherapy once daily for 24-27 fractions.
After completion of study treatment, patients are followed periodically for up to 8 years.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adjuvant therapy | Procedure | |||
| therapeutic conventional surgery | Procedure | |||
| intraoperative radiation therapy | Radiation | |||
| radiation therapy | Radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility | ||
| Acute tolerability | ||
| Local tumor control rate | ||
| Distant tumor control rate | ||
| Long-term side effects | ||
| Cosmetic outcome |
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DISEASE CHARACTERISTICS:
Histologically confirmed primary invasive breast carcinoma, meeting the following criteria:
No multicentric disease and/or diffuse malignant appearing microcalcifications
Any microcalcifications must be focal
No axillary lymph node involvement
Must have pathologically negative surgical margins
No evidence of metastatic breast cancer
Hormone receptor status not specified
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| William W. Wong, MD | Mayo Clinic | Study Chair |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D017024 | Chemotherapy, Adjuvant |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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| D017437 |
| Skin and Connective Tissue Diseases |