A Randomized Comparison of Radiation Therapy Techniques in the Management of Node Positive Breast Cancer
1. Primary Objective 1.1 To compare the extent of new myocardial perfusion defects
following breast cancer radiotherapy using the best standard 3-D radiotherapy
technique, partially wide tangent fields, versus the best optimized technique.
2. Secondary Objectives 2.1 To compare changes in ejection fraction and alterations in
cardiac wall motion with treatment by technique 2.2 To compare changes in lung
perfusion defects and pulmonary function tests (DLCO, FEV1, and FVC) by technique 2.3
To compare rates of pericarditis and pneumonitis by technique
Cardiac Endpoints: Myocardial SPECT-CT perfusion defects, ejection fraction, alterations in
cardiac wall motion, per SPECT-CT (adenosine stress and rest (if necessary)) scan.
Pulmonary Endpoints: Lung SPECT-CT perfusion defects per SPECT-CT scan, and changes in
pulmonary function tests: DLCO, FEV1, FVC Clinical Endpoints: pericarditis and pneumonitis.
Interventional
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
To compare the extent of new myocardial perfusion defects following breast cancer radiotherapy using the best standard 3-D radiotherapy technique, partially wide tangent fields, versus the best optimized technique.
approximately 1 year
Yes
Lori Pierce, MD
Principal Investigator
University of Michigan Cancer Center
United States: Institutional Review Board
UMCC 2004.038
NCT00581256
April 2006
December 2017
Name | Location |
---|---|
University of Michigan Health Systems | Ann Arbor, Michigan 48109 |