Although proton therapy was developed almost 80 years ago, widespread clinical implementation has been limited until the past decade. With the growing use of proton therapy, there is a desire to prove the equivalence or superiority of proton therapy across a number of cancer disease sites. Dozens of clinical trials have been developed to accomplish this within individual institutions, among a few centers, and across national and international networks such as the National Cancer Institute’s National Clinical Trial Network. The protocols include proton therapy imbedded in trials with photon therapy as well as randomized photon vs. proton trials. This chapter provides an overview of the design of such trials as well as some of the challenges facing protocols with proton therapy.
Part of the book: Proton Therapy
This chapter will provide an overview of quality assurance processes to credential proton therapy centers for clinical trial participation. There are a number of credentialing audit steps, including independent output verification, anthropomorphic phantom audits, image guidance credentialing, knowledge assessments, and on-site dosimetry review. The purpose of these credentialing steps is to ensure consistency across proton centers participating in clinical trials, and well as comparability with photon centers for randomized trials. This uniformity ensures high quality data for measuring patient outcomes, which are pivotal at a time when proton therapy is being assessed for superior outcomes.
Part of the book: Proton Therapy