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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA015083 | U.S. NIH Grant/Contract | View source | |
| MCS314 | Other Identifier | Mayo Clinic Cancer Center | |
| 806-04 | 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 intraoperative radiation therapy after lumpectomy followed by external-beam radiation therapy may kill any tumor cells that remain after surgery.
PURPOSE: This phase II trial is studying the side effects and how well radiation therapy works in treating women undergoing lumpectomy for stage I or stage IIA breast cancer.
OBJECTIVES:
OUTLINE: Patients undergo lumpectomy per standard procedures. Patients undergo intraoperative electron irradiation (IOERT) to the tumor bed right after completion of lumpectomy with axillary lymph node dissection or sentinel lymph node biopsy.
Beginning 2-6 weeks after lumpectomy with axillary lymph node dissection/sentinel lymph node sampling and IOERT, patients receive hypofractionated external-beam irradiation once daily for 16 days.
After completion of study treatment, patients are followed at 3 months, every 6 months for 5 years, and then annually thereafter for 8 years.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| adjuvant therapy | Procedure | |||
| conventional surgery | Procedure | |||
| hypofractionated radiation therapy | Radiation | |||
| intraoperative radiation therapy | Radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Toxicity: Up to 3 months post external beam radiation therapy | 3 months |
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DISEASE CHARACTERISTICS:
Histologically confirmed primary invasive breast carcinoma
Stage I-IIA disease (T1, N0, M0 or T2, N0, M0)
Pathologically determined single, discrete, and well-defined primary tumor ≤ 5 cm in diameter
No multicentric disease and/or diffuse malignant appearing microcalcifications
Micro-calcifications must be focal
No axillary lymph node involvement
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 |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D004358 | Drug Therapy |
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| D017437 |
| Skin and Connective Tissue Diseases |