A Phase I/II Trial to Evaluate Three Dimensional Conformal Radiation Therapy (3D-CRT) Confined to the Region of the Lumpectomy Cavity For Stage I And II Breast Carcinoma
Protocol Documents
Current Version Date: 9/30/2003
Principal Investigator: Frank A. Vicini, M.D.
Primary Objective: This study will evaluate the technical feasibility and reproducibility, cosmetic results, complication rates, and local control rate of 3D-CRT confined to the region of the lumpectomy cavity 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 (> 2 mm), up to 3 nodes positive at axillary dissection or sentinel lymph node biopsy, with no extensive intraductal component (EIC) by the Harvard definition.
Patient Population: Invasive ductal, medullary, papillary, colloid (mucinous), tubular histologies. AJCC Stage I or II (T1N0, T1N1, T2N0, T2N1); lesion <= 3 cm.
Target Accrual: 46
Current Accrual: 58
Status: Closed to Accrual
Date: 4/30/2004
Participating Sites:
| Annie Penn Memorial Hospital |
Reidsville |
NC |
| Arizona Oncology - Deer Valley Center |
Phoenix |
AZ |
| Arizona Oncology Services Foundation |
Scottsdale |
AZ |
| Beaumont CCOP |
Royal Oak |
MI |
| Cleveland Clinic Foundation |
Cleveland |
OH |
| Community Memorial Hospital |
Menomonee Falls |
WI |
| Cone Health Cancer Center |
Greensboro |
NC |
| Cross Cancer Institute |
Edmonton, Alberta |
|
| Dixie Medical Cancer Center |
East St. George |
UT |
| Hillcrest Hospital Cancer Center |
Mayfield Heights |
OH |
| Holy Cross Hospital Inc. |
Fort Lauderdale |
FL |
| Intermountain Medical Center |
Murray |
UT |
| Jupiter Medical Center |
Jupiter |
FL |
| LDS Hospital |
Salt Lake City |
UT |
| Logan Regional Hospital |
Logan |
UT |
| London Regional Cancer Program |
London Ontario |
|
| Mayo Clinic |
Rochester |
MN |
| McKay-Dee Hospital |
Ogden |
UT |
| Medical College of Wisconsin |
Milwaukee |
WI |
| Memorial Sloan-Kettering Cancer Center |
New York |
NY |
| Mount Sinai Comprehensive Cancer Center CCOP |
Miami Beach |
FL |
| Northwestern Memorial Hospital |
Chicago |
IL |
| Randolph Hospital |
Ashboro |
NC |
| Roswell Park Cancer Institute |
Buffalo |
NY |
| University of Colorado Denver |
Aurora |
CO |
| University of Texas-MD Anderson Cancer Center |
Houston |
TX |
| Utah Cancer Specialists |
Salt Lake City |
UT |
| Utah Valley Regional Medical Center |
Provo |
UT |
| Virginia Commonwealth University |
Richmond |
VA |
| Yale University |
New Haven |
CT |
Updated: 5/6/2011