Pragmatic Randomized Trial of Proton vs. Photon Therapy for Patients with Non-Metastatic Breast Cancer Receiving Comprehensive nodal Radiation: A Radiotherapy Comparative Effectiveness Trial
https://www.facingourrisk.org/research-clinical-trials/study/56/radcomp-a-study-at-the-heart-of-breast-cancer-treatment
Clinicaltrials.gov identifier:
NCT02603341 (https://clinicaltrials.gov/show/NCT02603341)
Study Contact Information:
For information about the study, contact: Hien Lu, Project Manager, by phone 215.662.6694 or by email.
About the Study
This study is no longer recruiting people.
The RadComp Study, short for Radiotherapy Comparative Effectiveness, is a nationwide clinical study comparing two FDA approved radiation therapies for the treatment of breast cancer, PHoton Therapy vs. PRoton Therapy. With any radiation treatment to the breast, the heart may be exposed to radiation potentially resulting in heart problems in the future. Both Photon and Proton therapies are FDA approved; however, to date doctors do not know which therapy is better or worse in terms of reducing side effects and promoting length and quality of life after radiation.
We hope to learn: The effectiveness of proton vs. photon therapy in reducing major cardiovascular events and how treatment affects patient’s quality of life, such as financial burden, fatigue, and anxiety. These objectives were chosen as study priorities by breast cancer patients themselves.
Type of Study
This a pragmatic randomized clinical trial in which patients (male or female) with locally advanced breast cancer will be randomized to either proton or photon therapy.
- Treatment Group 1: Receives PHoton Therapy once a day, 5 days a week, for 5 to 7 weeks
- Treatment Group 2: Receives PRoton Therapy once a day, 5 days a week, for 5 to 7 weeks
Participants will complete health questionnaires at various time points:
- at consent/when first joining the study
- 1 month follow-up
- 6 month follow-up
- once yearly after that
For convenience, participants have the option to fill these questionnaires out online or in-person during follow-up visits. Both treatment groups are then followed longitudinally (long-term) for 10 years to analyze health-related outcomes quality of life and cardiovascular morbidities.
This Study is Open To:
This study is no longer recruiting people.
This Study is Not Open To:
This study is no longer recruiting people.
About FORCE
FORCE is a national nonprofit organization, established in 1999. Our mission is to improve the lives of individuals and families affected by adult hereditary cancers.