A Phase I/II Trial to Evaluate Brachytherapy as the Sole Method of Radiation Therapy for Stage I and II Breast Carcinoma
Current Version Date: 2/14/2000
Principal Investigator: Robert R. Kuske, M.D.
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
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
|Cleveland Clinic Foundation
|Holy Cross Hospital Inc.
|Jupiter Medical Center
|Mount Sinai Comprehensive Cancer Center CCOP
|Ochsner Clinic CCOP
|University of Colorado Denver