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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA006927 | U.S. NIH Grant/Contract | View source | |
| 03026 | Other Identifier | Fox Chase 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 to damage tumor cells. Hypofractionated (fewer treatments than in standard radiation therapy) intensity-modulated radiation therapy (radiation directed at the tumor more precisely than in standard radiation therapy) with incorporated boost (an increase in the amount of radiation given during treatment) may kill more tumor cells.
PURPOSE: This phase II trial is studying how well adjuvant hypofractionated intensity-modulated radiation therapy with incorporated boost works in treating patients with early-stage breast cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients undergo adjuvant hypofractionated intensity-modulated radiotherapy with incorporated boost once daily 5 days a week for 4 weeks.
Quality of life is assessed within 1 month of starting radiotherapy, at 6 weeks after completion of radiotherapy, and then every 6 months for 5 years.
Patients are followed at 6 weeks and then every six months for 5 years.
PROJECTED ACCRUAL: A total of 37-74 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Radiation therapy | Experimental | Radiation Therapy Daily 5 days per week for 4 weeks 45 Gy in 20 fractions whole breast 56 Gy in 20 fractions to boost volume |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Radiation therapy | Radiation |
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| Measure | Description | Time Frame |
|---|---|---|
| Acute toxicity by CTCAE at 6 weeks | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life as measured by the Breast Cancer Treatment Outcome Scale (BCTOS) every 6 months for 5 years | every 6 months for 5 years |
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DISEASE CHARACTERISTICS:
Histologically confirmed carcinoma of the breast
Treated with breast-conserving surgery within the past 8 weeks
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
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| Name | Affiliation | Role |
|---|---|---|
| Penny Anderson, MD | Fox Chase Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111-2497 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D000071960 | Breast Carcinoma In Situ |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D002278 | Carcinoma in Situ |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |