IBA, Partners Launch Multi-site, Large-scale Proton Therapy Trial

IBA will conduct a large-scale, multi-institutional, randomized controlled clinical trial in conjunction with 19 industry and academic partners. Called the ProtectTrial, the consortium will conduct the trial in esophageal cancer patients with the aim of improving access to proton therapy for patients, while validating a model-based approach for the use of proton therapy treatment in cancer more broadly.  

The research project comprises 12 proton therapy centers across eight countries and is coordinated by Professor Cai Grau from Aarhus University in Denmark. IBA will offer its expertise within proton therapy solutions, with six of its centers involved in the trial. A total of approximately 400 patients are expected to be included in the randomized trial with study completion planned by 2027.

IBA is one of two industry participants supporting the project, which has received funding from the Innovative Medicines Initiative 2 (IMI2), Joint Undertaking under grant agreement No 101008134. This Joint Undertaking receives support from the European Union’s Horizon 2020 research and innovation program, European Federation of Pharmaceutical Industries and Associations (EFPIA) and the two industry partners.

Cancer of the esophagus is a complex disease with a relatively high occurrence and requiring complex multi-modality treatment associated with significant morbidity. In the ProtectTrial (PROton versus photon Therapy for Esophageal Cancer – a Trimodality strategy), the potential benefits of proton therapy will be tested in a trimodality treatment of radiotherapy, chemotherapy and surgery. It is hoped that the trial will produce high-quality data, which will contribute towards the creation of European guidelines on the use of proton therapy for esophageal cancer. 

The broader aim of the collaboration is to improve patient selection for proton therapy across cancer indications through the evaluation of selection criteria and the creation of shared reimbursement guidelines. A new consensus model would be of clear value across Europe, for both patient referral and treatment.

“This is the first European particle research project combining both the public and private sector,”said Professor Karin Haustermans, MD, PhD, from Katholieke Universiteit Leuven (KUL), co-Principal Investigator of ProtectTrial. “We are very grateful to IBA for supporting a project that reinforces a very solid collaboration between leading European centers and demonstrates the power of partnering across sectors and nationalities with the support from IMI and the proton therapy industry.”

“This significant project has the potential to produce high quality clinical data on the benefits of proton therapy”, said Olivier Legrain, Chief Executive Officer of IBA. “As our understanding of proton therapy’s efficacy grows, we believe this collaboration will help to define guidelines and selection criteria to make proton therapy more accessible to the patients who could benefit. We are very proud that six IBA proton therapy centers are contributing to the trial and we look forward to working with our partners to deliver high quality clinical evidence.”