Pragmatic Randomized Trial of Proton vs. Photon Therapy for Patients With Non-Metastatic Breast Cancer: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02603341|
Recruitment Status : Recruiting
First Posted : November 11, 2015
Last Update Posted : February 2, 2021
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Radiation: Photon Radiation: Proton||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||1278 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Pragmatic Randomized Trial of Proton vs. Photon Therapy for Patients With Non-Metastatic Breast Cancer: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial|
|Study Start Date :||February 2016|
|Estimated Primary Completion Date :||August 2022|
|Estimated Study Completion Date :||November 2032|
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
- Effectiveness of proton therapy vs. photon therapy [ Time Frame: 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).
- Disease Control [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 15 years ]To assess longer-term rates of breast cancer specific and overall survival and development of second malignancies.
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): NCT02603341
|Contact: Justin Bekelman, MDemail@example.com|
|Contact: Hien Lufirstname.lastname@example.org|
|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|