Pragmatic Clinical Trials of Proton vs Photon Therapy for Patients with Breast and Lung Cancer

Project: Research project

Project Details

Description

We propose superiority pragmatic randomized clinical trials in two clinical settings. The unifying hypothesis is that, as part of multi-modality curative treatment for locally-advanced breast and lung cancer, proton therapy reduces fatal and non-fatal major cardiovascular events compared to photon-based therapy. Fatal and non-fatal major cardiovascular events include cardiovascular heart disease death, myocardial infarction, cardiovascular revascularization procedures, and hospitalization for unstable angina. A complementary hypothesis is that proton therapy yields no worse breast and lung local-regional cancer recurrence than photon-based therapy. Each trial is designed with patient-centric short-term endpoints (both clinician and patient reported) that can be examined within the PCORI contract duration. We will evaluate meaningful long-term morbidity and mortality endpoints with future funding from NCI, PCORI or other agencies.
Setting 1. Post-mastectomy and locally-advanced breast cancer. H1. The proton beam therapy group will experience no worse local-regional cancer recurrence and reductions in long-term fatal and non-fatal major cardiovascular events.
Setting 2. Post-operative non-small cell lung cancer. The proton beam therapy group will experience no worse local-regional cancer recurrence and reductions in long-term fatal and non-fatal major cardiovascular events.
StatusActive
Effective start/end date11/1/1510/31/20

Funding

  • University of Pennsylvania (567804//PCS-1403-12804 002)
  • Patient-Centered Outcomes Research Institute (567804//PCS-1403-12804 002)

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