A Randomized Comparison of Radiation Therapy Techniques in the Management of Node Positive Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00581256|
Recruitment Status : Completed
First Posted : December 27, 2007
Results First Posted : December 1, 2016
Last Update Posted : October 31, 2017
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Radiation: IMRT Radiation: 3D||Phase 1 Phase 2|
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Comparison of Radiation Therapy Techniques in the Management of Node Positive Breast Cancer|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2016|
Best Delivery-optimized radiotherapy technique (IMRT)
All patients treated with the optimized plan will be treated to the entire target volume to 52.2 Gy in 1.74 Gy fractions, which is biologically equivalent to 50 Gy in 2 Gy fractions. This fractionation scheme will allow the boost of 10 Gy to be incorporated into the planning directive and to be delivered simultaneously with the treatment to the remaining target volume.
Active Comparator: 2
Best 3-dimensional standard PWTF technique
All patients treated using the best standard technique will receive 50 Gy in 2 Gy fractions or 50.4 Gy in 1.8 Gy fractions to the entire target volume delivering one treatment per day, five fractions per week (excluding holidays). A boost of 10 Gy to the tumor bed of an intact breast will be delivered. Patients treated to the chest wall will receive a 10Gy scar boost if mastectomy margins are positive in a patient with Stage II disease or if the patient was originally diagnosed with T3 or T4 (Stage III) disease
- The Number of Participants With a Significant Increase in Perfusion Defects (PD) [ Time Frame: 1 Year ]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. Perfusion defects (PD) were assessed by comparing normalized perfusion distributions against our institution's normal polar map databases for the left anterior descending artery (LAD) using thresholds of 2.5-SD (standard deviation) and 1.5-SD below the normal mean. On the basis of interest variability, a PD increase greater than 5% or 10% was considered significant for 2.5- and 1.5-SD thresholds, respectively.
- Mean Percent Change in Ejection Fraction (LVEF) [ Time Frame: baseline to approx 1 year ]To compare change in ejection fraction between treatment arms.
- Number of Participants With New Lung Perfusion Defects [ Time Frame: baseline to approx 1 year ]To compare changes in lung perfusion defects by treatment arm. Perfusion defects (PD) were assessed by comparing normalized perfusion distributions against our institution's normal polar map databases for the left anterior descending artery (LAD).
- The Number of Participants That Experience Pericarditis and Pneumonitis [ Time Frame: approx 1 year ]
To compare rates of pericarditis and pneumonitis by treatment arm.
Pericarditis (inflammation of the pericardium):
Grade1: Asymptomatic, ECG or physical exam; changes consistent with pericarditis Grade 2: Symptomatic pericarditis Grade 3: Pericarditis with physiologic consequences Grade 4: Life-threatening Pneumonitis (inflammation of the walls of the alveoli in the lungs) Grade 1: Asymptomatic, radiographic findings only Grade 2: Symptomatic, not interfering with ADL (activities of daily living) Grade 3: Symptomatic, interfering with ADL Grade 4: Life-threatening
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00581256
|United States, Michigan|
|University of Michigan Health Systems|
|Ann Arbor, Michigan, United States, 48109-5010|
|Principal Investigator:||Lori Pierce, MD||University of Michigan Rogel Cancer Center|