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RTOG 9517 Protocol Information

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A Phase I/II Trial to Evaluate Brachytherapy as the Sole Method of Radiation Therapy for Stage I and II Breast Carcinoma
Protocol Documents
Current Version Date: 2/14/2000
Principal Investigator: Robert R. Kuske, M.D.
Primary Objective:

This study will evaluate the technical feasibility and reproducibility, cosmetic results, complication rates, and local control rate of brachytherapy when used as the sole method of radiation therapy for patients with stage I and II (<= 3 cm) carcinoma of the breast (non-lobular histology) treated with tylectomy, with histologically assessed negative surgical margins, less than 4 positive nodes at axillary dissection, and without extra-capsular nodal extension or extensive intraductal component (EIC) by the Harvard definition

Patient Population:

Invasive ductal, medullary, papillary, colloid (mucinous), tubular histologies
Stages T1, T2, (lesions <= 3 cm) N0, N1 (up to 3 metastatic axillary lymph nodes with no extracapsular nodal extension [a minimum of 6 nodes in specimen], or a negative sentinel node is acceptable), M0
Six surgical clips placed at time of tylectomy to delineate target volume.
Unifocal breast cancer (single focus which can be encompassed by one tylectomy)
Unilateral breast cancer; no synchronous or previous contralateral breast cancer
Negative or close but negative microscopically-assessed surgical margins (see Section 10.6)
No extensive intraductal component (see Section 3.2.16)
No collagen vascular disease (see Section 3.2.7)
No known unresected residual carcinoma; no diffuse suspicious microcalcifications
No prior malignancy (< 5 years prior to enrollment in study) except non-melanoma skin cancer if continuously diseasefree
Negative post-tylectomy mammogram if cancer presented with malignancy-associated microcalcifications

Target Accrual: 92
Current Accrual: 100
Status: Terminated
Date: 11/5/2013
Participating Sites:
Beaumont CCOP Royal Oak MI
Cleveland Clinic Foundation Cleveland OH
University of Colorado Denver Aurora CO
Updated: 11/21/2013

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