Proton beam therapy (PBT) is a radical new type of advanced radiotherapy, capable of delivering and conforming a targeted dose of radiation to the tumour while causing minimal damage to the surrounding healthy tissue. In the past 5 years there has been a huge investment in high energy PBT across Europe and eleven member states now either have PBT in operation or are developing this capability. In addition, the two largest manufactures of PBT equipment have based their manufacturing in Europe. This integrating activity INSPIRE, aims to link these clinical PBT centres in eleven different countries together with two associated centres in USA. It also brings in two of the worlds largest manufacturers of PBT equipment and an SME. The trans-national access in INSPIRE will provide European researchers with access to “state of the art” research capabilities employing proton beams at clinical energies. INSPIRE represents an integrating activity across Europe in a multi-disciplinary field that is growing exponentially. Through its Networking, Transnational Access and Joint Research Activities, INSPIRE seeks to provide the “state of the art” capabilities that are needed to address the key challenges in this rapidly developing field. INSPIRE has at its heart the principles of responsible research and innovation and will communicate its research and give access to its databases and software through an Open Access Gateway. INSPIRE will contain a pipeline of innovation through its Innovation Gateway, to accelerate research for patient and commercial benefit. INSPIRE will provide its researchers with an unrivalled research and training and opportunities to “discipline hop” into the industrial, clinical or industrial environment. INSPIRE integrates activities across Europe in this rapidly growing area and offers European researchers unrivalled access to state of the art research capabilities in an area where there has already been significant government investment.

The aim of PROTECT-trial is to compare the clinical outcome of proton therapy (PT) and conventional radiotherapy in a randomized study and to use the data and experience to advance the field of evidence-based medicine in PT. A randomized trial with 396 patients is planned involving 13 recruiting units and 34 institutions from nine European countries in an accrual period of three years. All involved PT centers have state-of-the-art equipment, including pencil beam scanning and volumetric image guidance. The endpoints will include side effects, tumor control, survival, and health economics aspects. PROTECT-trial will use experience from the trial, combined with parallel experience from other trial methodologies, to create a consensus model for the selection of patients both for referral for standard PT and for enrollment in clinical trials. This model will be based on esophageal cancer but will have wider implications, which can be used in all European countries and for other cancer types. PROTECT-trial will result in new evidence for the role of PT in cancer management. PROTECT-trial will advance the quality of care for trimodality management of esophageal cancer. The large trial will provide statistically robust results at a high level of clinical evidence and will allow a successful trial to trigger an international change in clinical practice. If the PROTECT trial is positive, PT will become a standard option for a large patient population. The patients will recover faster from their treatment and live a better life with fewer side effects and more years at work. The results will have high relevance for other cancer types where protons also lower the dose to sensitive normal tissues. Notably, PROTECT-trial will actively engage with patients, providers, payers, and other stakeholders to design and report the study. Finally, PROTECT-trial will contribute with Health Technology Assessment and provide economic evidence of high relevance to reimbursement decisions in Europe.