DOI: 10.3886/icpsr36994.v1
title: 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]
title: Version 1

description: 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.
description: The study's primary objective was to assess 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 events (heart failure, valvular disease, arrhythmia, or unstable angina or some other major cardiovascular event). Secondary objectives of the study included: Assessing 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). Assessing 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. Developing predictive models to examine the association of radiation dose distribution (to heart and other normal tissues) and MCE and HRQOL outcomes. Assessing longer-term rates of breast cancer specific and overall survival and development of second malignancies.
description: This study was a superiority pragmatic randomized clinical trial to compare external beam radiation therapits (proton and photon therapy). Patients were stratified according to age (&lt;65 years old vs ≥ 65 years old), cardiovascular risk (0 or 1 or 2 risk factors vs &gt; 2 risk factors), surgery (mastectomy vs. lumpectomy) and laterality (left vs. right sided). Patients were randomized using permuted block randomization scheme to receive photon or proton therapy. At baseline, researchers recorded tumor characteristics and mastectomy, lumpectomy, or local excision status and details. In addition, prior to beginning either form of radiation therapy, researchers collected information about cardiovascular risk factors, sociodemographics and co-morbidities, contact information and insurance data, as well as medication use. Following treatment, participants were interviewed either in person or by telephone to gather information about breast cancer recurrance and major cardiovascular events. This included a cancer control case report, a second malignancy case report, toxicity and adverse events data, a clinician reported events case report, and radiotherapy treatment data. A search of the National Death Index was conducted during the final year of the study to obtain survival and cause-of-death data for all patients enrolled.
description: The data are unweighted.
description: Females or males seen at a RADCOMP facility diagnosed with pathologically (histologically) proven invasive mammary carcinoma (ductal, lobular or other) of the breast who have undergone either mastectomy or lumpectomy/local excision with any type of axillary or internal mammary node chain surgery or sampling were eligible to participate. Over 48 months of data collection, 1,716 patients were recruited for participation in the study. Patients were required to have the psychological ability and general health that permited informed consent, completion of the study requirements, and required follow up. For patients who had undergone lumpectomy, any type of mastectomy and any type of reconstruction (including no reconstruction) were allowed. For patients who had undergone lumpectomy, there were no breast size limitations. Patients with non-metastatic breast cancer were also eligible. This included 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 received neoadjuvant chemotherapy, AJCC 7th edition left- or right-sided breast cancer pathologic stage yp 0, I, II, III were eligible. Bilateral breast cancer was also permitted. Patients with bilateral breast cancer were stratified as left-sided. The following additional eligibility criteria were used to build the sample for the study: 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 would not cover a specific treatment in the study and the patient still wanted to participate, confirmation that the patient would be responsible for paying for any treatment received was required. Patients who are HIV positive were eligible, provided they were under treatment with highly active antiretroviral therapy (HAART) and had a CD4 count ≥ 200 cells/microliter within 180 days prior to registration as documented in the medical record. HIV testing was not required for eligibility for this protocol. Individuals with prior radiotherapy in the contralateral breast or chest wall were eligible. Patients with one or more of the following conditions were not eligible for the study: 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. 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.
description: Datasets:
description: Patients age 21 and above seen in any of the 22 RADCOMP centers with stage II or III breast cancer.
description: face-to-face interview; mixed mode; telephone interviewThese data are being released for demonstration only - do not cite.Additional information about 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 study can be found on the PCORI project website.This study was used during the pilot phase of the PCODR archive, but was not selected for inclusion in the repository. The data is not available from ICPSR. For more information about the Patient-Centered Outcomes Data Repository, please visit the PCODR website.