Pragmatic Randomized Trial of Proton vs. Photon Therapy for Patients With Non-Metastatic Breast Cancer: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial
A pragmatic randomized clinical trial of patients with locally advanced breast cancer randomized to either proton or photon therapy and followed longitudinally for cardiovascular morbidity and mortality, health-related quality of life, and cancer control outcomes. Quality of life is the outcome measure for the estimated primary completion date of August, 2022, www.radcomp.org.
|Condition or Disease||Intervention/Treatment||Phase|
Because no one knows which radiation treatment is best, if you decide to take part in this study, you will be randomly assigned to 1 of 2 treatment groups, and then you will begin radiation treatment according to usual medical practice. Randomly assigning you to a group helps makes sure that each group has a similar mix of patients and makes the study better - and is only done when doctors are not sure whether one treatment is better than the other. You have an equal chance of getting into either treatment group, like a coin flip. Both you and your doctor will be told which treatment you will get.
No matter which group patients are in, doctors will work very carefully to reduce the radiation to healthy tissues. Both groups will followed for at least 10 years after completing radiation therapy. The results of this study will help decide which radiation is best for future patients with your type of breast cancer.
Arms and Interventions
|Active Comparator: Photon
Photon therapy: once a day, 5 days a week, for 5 to 7 weeks
Photon Therapy:once a day, 5 days a week, for 5 to 7 weeks
|Active Comparator: Proton
Proton therapy: once a day, 5 days a week, for 5 to 7 weeks
Proton Therapy: once a day, 5 days a week, for 5 to 7 weeks
Primary Outcome Measures
- Effectiveness of proton therapy vs. photon therapy [10 years]
Compare the effectiveness of proton vs. photon therapy in reducing major cardiovascular events (MCE), defined as atherosclerotic coronary heart disease or other heart disease death, myocardial infarction, coronary revascularization, or hospitalization for major cardiovascular event (heart failure, valvular disease, arrhythmia, or unstable angina).
Secondary Outcome Measures
- Disease Control [5 years]
Compare the non-inferiority of proton vs. photon therapy in reducing ipsilateral breast cancer local-regional recurrence and in reducing any recurrence, defined as the first reported breast cancer recurrence of any type (local-regional or distant or cancer-specific mortality)
- Quality of Life [5 years]
Compare the effectiveness of proton vs. photon therapy in improving patient-reported body image and function, fatigue and other measures of health-related quality of life (HRQOL) (anxiety, social roles, financial toxicity, general satisfaction) and adverse events.
- Radiation Dose and Quality of Life and Cardiac Toxicity [5 years]
Develop predictive models to examine the association of radiation dose distribution (to heart and other normal tissues) and major cardiovascular events and quality of life outcomes.
- Long Term Survival [15 years]
To assess longer-term rates of breast cancer specific and overall survival and development of second malignancies.
Females or males diagnosed with pathologically (histologically) proven invasive mammary carcinoma (ductal, lobular or other) of the breast who have undergone either mastectomy or lumpectomy with any type of axillary surgery or axillary sampling.
For patients who have undergone lumpectomy, any type of mastectomy and any type of reconstruction (including no reconstruction) are allowed.
For patients who have undergone lumpectomy, there are no breast size limitations.
Patients with non-metastatic breast cancer are eligible. This includes American Joint Committee on Cancer (AJCC) 7th edition left- or right-sided breast cancer clinical or pathologic stage I, II, III or loco-regionally recurrent at time of diagnosis. For patients that receive neoadjuvant chemotherapy, AJCC 7th edition left- or right-sided breast cancer pathologic stage yp 0, I, II, III are eligible.
Bilateral breast cancer is permitted. Patients with bilateral breast cancer will be stratified as left-sided.
Must be proceeding with breast/chest wall and nodal radiation therapy including internal mammary node treatment.
Must have a pertinent history/physical examination within 90 days prior to registration.
Age ≥ 21 years
ECOG Performance Status 0 - 2 (asymptomatic to symptomatic but capable of self-care) within 90 days prior to randomization.
Confirmation that the patient's health insurance will pay for the treatment in this study (patients may still be responsible for some costs, such as co-pays and deductibles). If the patient's insurance will not cover a specific treatment in this study and the patient still wants to participate, confirmation that the patient would be responsible for paying for any treatment received.
Patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter within 180 days prior to registration as documented in the medical record. HIV testing is not required for eligibility for this protocol.
The patient must provide study-specific informed consent prior to study entry.
Definitive clinical or radiologic evidence of metastatic disease, as documented by the treating institution.
Prior radiotherapy to the ipsilateral chest wall or ipsilateral breast or thorax. Individuals with prior radiotherapy in the contralateral breast or chest wall are eligible.
Any radiation therapy for the currently diagnosed breast cancer prior to randomization.
Dermatomyositis with a CPK level above normal or with an active skin rash or scleroderma.
Other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up.
Contacts and Locations
|1||University of Alabama||Birmingham||Alabama||United States||35233|
|2||Mayo Clinic-Arizona||Phoenix||Arizona||United States||85054|
|3||UC San Diego||San Diego||California||United States||92121|
|4||Georgetown University Medical Center||Washington||District of Columbia||United States||20007|
|5||University of Miami Sylvester Cancer Center at Coral Gables||Coral Gables||Florida||United States||33146|
|6||University of Miami Sylvester Cancer Center - Deerfield||Deerfield Beach||Florida||United States||33442|
|7||University of Florida Health||Gainesville||Florida||United States||32610|
|8||University of Florida Health Proton Therapy Institute||Jacksonville||Florida||United States||32206|
|9||Mayo Clinic Florida||Jacksonville||Florida||United States||32224|
|10||University of Miami Sylvester Cancer Center||Miami||Florida||United States||33136|
|11||Miami Cancer Insititute||Miami||Florida||United States||33176|
|12||Orlando Health||Orlando||Florida||United States||32806|
|13||Emory University||Atlanta||Georgia||United States||30322|
|14||Northwestern Medicine Proton Center||Chicago||Illinois||United States||60190|
|15||Willis Knighton||Shreveport||Louisiana||United States||71103|
|16||University of Maryland||Baltimore||Maryland||United States||21201|
|17||Johns Hopkins||Baltimore||Maryland||United States||21287|
|18||Massachusetts General Hospital||Boston||Massachusetts||United States||02114|
|19||Mass General/North Shore Cancer Center||Danvers||Massachusetts||United States||01923|
|20||McLaren Proton Therapy||Flint||Michigan||United States||48532|
|21||William Beaumont||Royal Oak||Michigan||United States||48073|
|22||Mayo Clinic-Rochester||Rochester||Minnesota||United States||55905|
|23||Washington University, St. Louis||Saint Louis||Missouri||United States||63110|
|24||RWJ University Hospital Hamilton||Hamilton||New Jersey||United States||08690|
|25||Cancer Institute of NJ||New Brunswick||New Jersey||United States||08903|
|26||ProCure Proton Therapy Center||Somerset||New Jersey||United States||07728|
|27||New York Proton Center||New York||New York||United States||10035|
|28||Memorial Sloan Kettering Cancer Center||New York||New York||United States||10065|
|29||University of Cincinnati||Cincinnati||Ohio||United States||45267|
|30||University Hospitals, Case Medical Center||Cleveland||Ohio||United States||44106|
|31||University Pointe, University of Cincinnati||West Chester||Ohio||United States||45069|
|32||Oklahoma University - Stephenson Cancer Center||Oklahoma City||Oklahoma||United States||73104|
|33||Oklahoma City Procure||Oklahoma City||Oklahoma||United States||73142|
|34||Pinnacle Health Cancer Institute||Harrisburg||Pennsylvania||United States||17109|
|35||Abramson Cancer Center of the University of Pennsylvania||Philadelphia||Pennsylvania||United States||19104|
|36||Chester County Hospital||West Chester||Pennsylvania||United States||19380|
|37||Provision Center for Proton Therapy||Knoxville||Tennessee||United States||37909|
|38||MD Anderson Cancer Center||Houston||Texas||United States||77030|
|39||Texas Center for Proton Therapy||Irving||Texas||United States||75063|
|40||Seattle Cancer Care Alliance||Seattle||Washington||United States||98133|
|41||University of Washington||Seattle||Washington||United States||98195|
Sponsors and Collaborators
- Abramson Cancer Center of the University of Pennsylvania
- Patient-Centered Outcomes Research Institute
- Principal Investigator: Justin Bekelman, MD, Abramson Cancer Center of the University of Pennsylvania
- Study Chair: Oren Cahlon, MD, Memorial Sloan Kettering Cancer Center
- Study Chair: Shannon MacDonald, MD, Massachusetts General Hospital
Study Documents (Full-Text)None provided.
- UPCC 19115