A Randomized Comparison of Radiation Therapy Techniques in the Management of Node Positive Breast Cancer
Radiotherapy has been shown to reduce breast-cancer specific mortality in patients at high risk for distant dissemination. It has also been shown to increase rates of non-breast cancer deaths and morbidity due to cardiovascular and pulmonary toxicity. Although treatment planning has improved significantly through the years, recent reports still demonstrate treatment-related morbidity even with 3-dimensional planned techniques. Thus, while 3D planning represents the state of the art treatment for loco-regional radiotherapy for breast cancer, further improvement is needed to continue to decrease heart and lung exposure. The ultimate goal of the proposed research is to determine whether treatment planning using intensity-modulated radiotherapy (IMRT), the "next generation" of radiation treatment delivery systems, results in less radiation exposure to the heart and lungs than the best current RT technique in women with node positive breast cancer. This proposal will test the potential clinical value of IMRT compared to the best standard 3D plan (partially wide tangent fields, PWTF) in the treatment of breast cancer. These two treatment techniques will be studied in a Phase II randomized trial using quantitative indicators of potential cardiac and lung toxicity. The preliminary data generated from this trial will be used to ultimately justify a multi-institutional comparison of the two treatment techniques with long-term clinical cardiac and pulmonary toxicity as endpoints.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Comparison of Radiation Therapy Techniques in the Management of Node Positive Breast Cancer|
- 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. [ Time Frame: approximately 1 year ] [ Designated as safety issue: Yes ]
- To compare changes in ejection fraction and alterations in cardiac wall motion with treatment by technique [ Time Frame: approx 1 year ] [ Designated as safety issue: Yes ]
- To compare changes in lung perfusion defects and pulmonary function tests (DLCO, FEV1, and FVC) by technique [ Time Frame: approx 1 year ] [ Designated as safety issue: Yes ]
- To compare rates of pericarditis and pneumonitis by technique [ Time Frame: approx 1 year ] [ Designated as safety issue: Yes ]
|Study Start Date:||April 2006|
|Estimated Study Completion Date:||December 2017|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00581256
|United States, Michigan|
|University of Michigan Health Systems|
|Ann Arbor, Michigan, United States, 48109-5010|
|Principal Investigator:||Lori Pierce, MD||University of Michigan Cancer Center|