Pragmatic Phase III Randomized Trial of Proton vs. Photon Therapy for Patients with Non-Metastatic Breast Cancer Receiving Comprehensive Nodal Radiation: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial [United States]

The Pragmatic Phase III Randomized Trial of Proton vs. Photon Therapy for Patients with Non-Metastatic Breast Cancer Receiving Comprehensive Nodal Radiation: A Radiotherapy Comparative Effectiveness (RADCOMP) Consortium Trial data collection is a collection of images obtained by the RADCOMP Consortium as part of a Randomized Trial comparing proton vs photon therapy techniques on Breast Cancer patients. The Radiotherapy Comparative Effectiveness (RADCOMP) Consortium conducted a pragmatic randomized clinical trial, in which 1,716 patients with stage II and III breast cancer involving lymph nodes under the arm or above the collar bone were randomized after surgery to either proton therapy or photon therapy. Photon therapy is the current standard treatment, and proton therapy is an alternative radiation treatment for breast cancer which uses proton beams that slow down as they travel through the body and scatter fewer x-rays. The RADCOMP study images were gathered to assess the effectiveness of proton versus photon therapy on reducing major cardiovascular events. Researchers utilized these images and follow-ups to determine therapy effectiveness on participant's cardiovascular morbidity and mortality, health-related quality of life, and cancer control outcomes. Patients were followed post treatment to determine differences in heart problems, cancer control, and health related quality of life (HRQOL). Primary outcomes measured were the frequency of cardiovascular events, such as heart attacks or chest pain. Cancer control outcomes including breast cancer recurrence were also measured. Lastly, researchers measured HRQOL outcomes, which included body image and function, fatigue, anxiety, social roles, side effects burden, financial burden, and satisfaction, as well as general HRQOL. DICOM data derived from captured images are included in this collection, as well as Radialogica FullAccess (Windows) executable viewer packages for each case. A spreadsheet listing DICOM Series for each case was provided. Demographic information within this collection include: age, race, ethnicity, education, and marital status.