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Title:
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A Randomized Phase III Study of Conventional Whole Breast Irradiation (WBI) Versus Partial Breast Irradiation (PBI) for Women with Stage 0, I, or II Breast Cancer - IRB# 05-53A
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Treatments:
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Partial Breast Irradiation, Whole Breast Irradiation
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Disease Site:
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Breast
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Disease SubSite:
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Drug Provided:
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-- none --
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Comments:
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Investigators must be credentialed in order to enroll participants
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Eligibility:
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Histologically confirmed ductal carcinoma in situ (DCIS) or invasive adenocarcinoma of the breast . Stage 0, I, or II disease , Stage II tumors must be =< 3 cm, Gross disease must be unifocal , Microscopic multifocality allowed provided total pathological tumor size is =< 3 cm, No proven multicentric carcinoma in more than 1 quadrant or separated by = 4 cm , No non-epithelial breast malignancies (e.g., sarcoma or lymphoma), Prior axillary staging required for patients with invasive breast cancer, including 1 of the following: Sentinel node biopsy alone (if sentinel node is negative) , Sentinel node biopsy followed by axillary dissection or sampling with => 6 axillary nodes (if sentinel node is positive) , Axillary dissection alone with => 6 axillary nodes, No more than 3 positive axillary nodes , No axillary nodes with definite evidence of microscopic or macroscopic extracapsular extension , No positive non-axillary sentinel nodes (intramammary nodes are staged as axillary nodes). No palpable or radiographically suspicious ipsilateral or contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes unless there is histologic confirmation that these nodes are negative for tumor. Must have undergone lumpectomy. Resected margins histologically free of tumor. Re-excision of surgical margins allowed. Target lumpectomy cavity clearly delineated AND target lumpectomy/whole breast reference volume =< 30% based on postoperative CT scan. Final surgery (i.e., lumpectomy, re-excision of margins, or axillary staging procedure) within the past 42 days. No suspicious microcalcifications, densities, or palpable abnormalities in the ipsilateral or contralateral breast unless biopsied and found to be benign. No Paget’s disease of the nipple. No history of invasive breast cancer or DCIS, Prior lobular carcinoma in situ treated by surgery alone allowed. No synchronous bilateral invasive or non-invasive breast cancer.
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Participating Sites:
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Adventist Medical Center, Providence Portland Medical Center, Providence St. Vincent Medical Center
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