ANNUAL OCT. 31-NOV. 2, 2017 MEETING ARLINGTON, VA A Study at the Heart of Breast Cancer Treatment Hien Lu RadComp Project Manager November 1, 2017 #PCORI2017
ANNUAL MEETING | #PCORI2017 Hien Lu • Has nothing to disclose. November 5, 2017 2
ANNUAL MEETING | #PCORI2017 Objectives At the conclusion of this activity, the participant should be able to: • Describe the RadComp trial and its data sources • Identify challenges to data sharing November 5, 2017 3
ANNUAL MEETING | #PCORI2017 Overview • Study Overview • Data Sources • Challenges November 5, 2017 4
ANNUAL MEETING | #PCORI2017 Study Overview • Aim: To assess the effectiveness of proton vs. photon therapy in reducing major cardiovascular events (MCE) for patients with locally advanced breast cancer • Primary hypothesis: Proton therapy will reduce the 10-year MCE rate after radiation from 6.3% to 3.8% • Sample size: 1,716 patients • Sites approved for accrual: 19 proton centers and >30 participating radiation treatment centers across US • Large, simple trial approaches: Passive and active follow-up techniques A randomized pragmatic trial funded by PCORI
ANNUAL MEETING | #PCORI2017 Primary Objective • To assess the effectiveness of proton vs. photon therapy in reducing major cardiovascular events (MCE) • Primary hypothesis: For patients with locally advanced breast cancer, proton therapy will reduce the 10-year MCE rate after radiation from 6.3% to 3.8%. • Sample size: 1,716 patients
ANNUAL MEETING | #PCORI2017 Secondary Objectives • To assess the non-inferiority of proton vs. photon therapy in reducing ipsilateral breast cancer local-regional recurrence and in reducing any recurrence • With 1,716 patients, there is 80% power for a 5-year non- inferiority margin not higher than 3.5% for local-regional recurrence assuming local-regional recurrence in the photon arm of 5% at 5 years • To assess 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) and adverse events. • To develop predictive models to examine the association of radiation dose distribution to heart and MCE and HRQOL outcomes.
ANNUAL MEETING | #PCORI2017 Data Sources - Radiorespository • Primary Data (DICOM, Full Access): • Treatment Planning Images • Target Volumes and Organ Contours • Radiation Treatment Plans • Dose distribution • Prescriptions • Secondary Data (CSV, DICOM): • Plan review scores • Dosimetric Values • Heart sub-volume contours • Dose Volume Histogram
ANNUAL MEETING | #PCORI2017 Data Sources – Medidata Rave • Baseline Patient and Tumor Characteristics • HRQOL • Fatigue, body image, adverse effects of treatment • Via VisionTree for consenting patients • Cancer Recurrence • Adverse Events • Treatment summary • Non-protocol treatment, medical services, second primaries
ANNUAL MEETING | #PCORI2017 Data Sources – Secure Portal • Protected Health Information • SSN • Alternate contacts • Insurance • Healthcare Providers
ANNUAL MEETING | #PCORI2017 Technical Challenges • Multiple data sources; no central repository • Active study November 5, 2017 11
ANNUAL MEETING | #PCORI2017 Governance Challenges • Multi-site trial • Not all sites utilizing a central IRB • Institution-specific Contractual language • ICF language • Re-consent barriers November 5, 2017 12
ANNUAL MEETING | #PCORI2017 Learn More • www.radcomp.org • radcomp@uphs.upenn.edu • https://www.youtube.com/watch?v=skqPHTPslvo November 5, 2017 13
ANNUAL MEETING | #PCORI2017 Questions? November 5, 2017 14
ANNUAL MEETING | #PCORI2017 Thank You! Hien Lu November 1, 2017 November 5, 2017 15
ANNUAL MEETING | #PCORI2017 Appendix November 5, 2017 16
ANNUAL MEETING | #PCORI2017 RadComp Radiorepository Data Flow (1) Planning CT (2) Manually segmented heart sub-structures, lung, esophagus, thyroid) (3) Autosegmented heart sub-structures, lung, esophagus, thyroid); out-of-field Dose * External review of treatment planning data (anonymized FullAccess viewer package)
ANNUAL MEETING | #PCORI2017 Curation of Dosimetric Data • TCIA Curation • De-identification • Relative dates • Hidden PHI • DICOM Conformance • RT object linkage • Private tags
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