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General Eligibility: |
All patients must be women of at least 18 years of age, who are not pregnant or lactating and have a life expectancy of
at least 10 years. Eligible patients will have stage 0, I, or II breast cancer and those who are stage II must have a tumor
of 3 cm or less in size. Upon histological examination all tumor must be DCIS or invasive adenocarcinoma of the breast. All gross disease must be unifocal with pathologic tumor size of 3 cm or less. Patients with microscopic multifocality are eligible provided the total pathologic tumor size is 3 cm or less. Patients with more than 3
positive axillary nodes, or axillary nodes with definite evidence of microscopic or macroscopic extracapsular extension, or non-axillary sentinel nodes will be considered ineligible. Patients with a history of nonbreast malignancies are eligible if they have been disease-free for 5 or more years prior to randomization and are
deemed by their physician to be at low risk for recurrence. Patients with proven multicentric carcinoma (invasive cancer or DCIS) in more than one quadrant or separated by more than 4 cm will be considered ineligible. Patients with Paget’s disease of the nipple, prior breast or thoracic RT for any condition, collagen vascular disease, or breast implants will be considered ineligible. Patients who have a history of invasive breast cancer or DCIS, except those
with a history of LCIS treated by surgery alone, are considered ineligible.
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Purpose: |
Primary:
• To determine whether partial breast irradiation (PBI) limited to the region of the tumor bed following lumpectomy provides equivalent local tumor control in the breast compared to conventional whole breast (WBI) in the local management of early stage breast cancer.
Secondary:
• To compare overall survival, recurrence-free survival, and distant disease-free survival, between women receiving PBI and women receiving WBI.
• To determine whether PBI delivered in 5 treatment days can provide a comparable cosmetic result to WBI.
• To determine if perceived convenience of care is greater for women receiving PBI compared to women receiving WBI.
• To compare acute and late toxicities between the radiation therapy regimens.
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Treatment: |
Group 1 : whole breast irradiation WBI 45-50 Gy in 25 (1.8-2.0 Gy) fractions to whole breast followed by boost to = 60 Gy
Group 2 : Partial breast irradiation (PBI)
34 Gy in 3.4 Gy fractions using mulit-catheter brachytherapy
or
34 Gy in 3.4 Gy fractions using Mammosite ® balloon catheter
or
38.5 Gy in 3.85 Gy fractions using 3D conformal external beam radiation
For all PBI techniques: RT given to index quadrant only; BID (with a fraction separation of at least 6 hours ) for a total of 10 treatments given on 5 days over a period of 5-10 days
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