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To determine if hypofractionated radiotherapy to the whole breast (4,250 cGy/16 fractions over 22 days) is equally effective to standard fractionated radiotherapy (5,000 cGy/25 fractions over 35 days) in women with node negative breast cancer who have undergone lumpectomy.
The primary outcome is local breast recurrence and secondary outcomes include morbidity and cost effectiveness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hypofractionated whole breast radiation | Experimental | Subjects treated with 4250 cGY in 16 fractions |
|
| Conventional whole breast radiation | Active Comparator | Subjects treated with 5000 cGY in 25 fractions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Conventional whole breast radiation schedule | Radiation |
| ||
| Hypofractionated whole breast radiation schedule |
| Measure | Description | Time Frame |
|---|---|---|
| Local breast recurrence | Indefinitely |
| Measure | Description | Time Frame |
|---|---|---|
| Morbidity | Indefinitely | |
| Cost effectiveness | Indefinitely |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tim Whelan, MD | Juravinski Cancer Centre | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Regional Cancer Program of the Sudbury Regional Hospital | Greater Sudbury | Ontario | P3E 5J1 | Canada | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12165639 | Result | Whelan T, MacKenzie R, Julian J, Levine M, Shelley W, Grimard L, Lada B, Lukka H, Perera F, Fyles A, Laukkanen E, Gulavita S, Benk V, Szechtman B. Randomized trial of breast irradiation schedules after lumpectomy for women with lymph node-negative breast cancer. J Natl Cancer Inst. 2002 Aug 7;94(15):1143-50. doi: 10.1093/jnci/94.15.1143. | |
| 20147717 |
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| Radiation |
|
| Juravinski Cancer Centre |
| Hamilton |
| Ontario |
| L8V 5C2 |
| Canada |
| Cancer Centre of Southeastern Ontario at Kingston General Hospital | Kingston | Ontario | K7L 5P9 | Canada |
| London Regional Cancer Centre | London | Ontario | N6A 4L6 | Canada |
| Ottawa Hospital-Integrated Cancer Program | Ottawa | Ontario | K1H 1C4 | Canada |
| Niagara Health System | St. Catharines | Ontario | L2R 5K3 | Canada |
| Regional Cancer Care - Thunder Bay HSC | Thunder Bay | Ontario | P7B 6V4 | Canada |
| Toronto Sunnybrook Regional Cancer Centre | Toronto | Ontario | M4N 3M5 | Canada |
| The Princess Margaret Hospital | Toronto | Ontario | M5G 2M9 | Canada |
| Windsor Regional Cancer Centre | Windsor | Ontario | N8W 2X3 | Canada |
| Montreal General Hospital | Montreal | Quebec | H3G 1A4 | Canada |
| Whelan TJ, Pignol JP, Levine MN, Julian JA, MacKenzie R, Parpia S, Shelley W, Grimard L, Bowen J, Lukka H, Perera F, Fyles A, Schneider K, Gulavita S, Freeman C. Long-term results of hypofractionated radiation therapy for breast cancer. N Engl J Med. 2010 Feb 11;362(6):513-20. doi: 10.1056/NEJMoa0906260. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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