A Study at the Heart of Breast Cancer Treatment Hien Lu RadComp - - PowerPoint PPT Presentation

▶
a study at the heart of breast cancer treatment
SMART_READER_LITE
LIVE PREVIEW

A Study at the Heart of Breast Cancer Treatment Hien Lu RadComp - - PowerPoint PPT Presentation

Nov 10, 2023 245 likes •447 views

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,

slide-1
SLIDE 1

ANNUAL MEETING

  • OCT. 31-NOV. 2, 2017

ARLINGTON, VA

#PCORI2017

A Study at the Heart of Breast Cancer Treatment

Hien Lu

RadComp Project Manager November 1, 2017

slide-2
SLIDE 2

ANNUAL MEETING | #PCORI2017

2

Hien Lu

  • Has nothing to disclose.

November 5, 2017

slide-3
SLIDE 3

ANNUAL MEETING | #PCORI2017

3

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

slide-4
SLIDE 4

ANNUAL MEETING | #PCORI2017

4

Overview

  • Study Overview
  • Data Sources
  • Challenges

November 5, 2017

slide-5
SLIDE 5

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

slide-6
SLIDE 6

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
slide-7
SLIDE 7

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

  • f 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.

slide-8
SLIDE 8

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
slide-9
SLIDE 9

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

slide-10
SLIDE 10

ANNUAL MEETING | #PCORI2017

Data Sources – Secure Portal

  • Protected Health Information
  • SSN
  • Alternate contacts
  • Insurance
  • Healthcare Providers
slide-11
SLIDE 11

ANNUAL MEETING | #PCORI2017

11

Technical Challenges

  • Multiple data sources; no central repository
  • Active study

November 5, 2017

slide-12
SLIDE 12

ANNUAL MEETING | #PCORI2017

November 5, 2017 12

Governance Challenges

  • Multi-site trial
  • Not all sites utilizing a central IRB
  • Institution-specific Contractual language
  • ICF language
  • Re-consent barriers
slide-13
SLIDE 13

ANNUAL MEETING | #PCORI2017

13

Learn More

  • www.radcomp.org
  • radcomp@uphs.upenn.edu
  • https://www.youtube.com/watch?v=skqPHTPslvo

November 5, 2017

slide-14
SLIDE 14

ANNUAL MEETING | #PCORI2017

14

Questions?

November 5, 2017

slide-15
SLIDE 15

ANNUAL MEETING | #PCORI2017

November 5, 2017 15

Thank You!

Hien Lu

November 1, 2017

slide-16
SLIDE 16

ANNUAL MEETING | #PCORI2017

November 5, 2017 16

Appendix

slide-17
SLIDE 17

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);

  • ut-of-field Dose

* External review of treatment planning data (anonymized FullAccess viewer package)

slide-18
SLIDE 18

ANNUAL MEETING | #PCORI2017

Curation of Dosimetric Data

  • TCIA Curation
  • De-identification
  • Relative dates
  • Hidden PHI
  • DICOM Conformance
  • RT object linkage
  • Private tags