Spread across Europe, 19 industry and academic partners have launched a large-scale, clinical trial aimed at extending the reach of proton therapy and tailoring patient selection to those who are likely to benefit from it the most.
The randomized controlled ProtectTrial will oversee the use of proton therapy on approximately 400 patients with esophageal cancer, with the aim of improving access to PT for such patients. At the same time, researchers involved will evaluate selection criteria and create shared reimbursement guidelines that will better ensure proton therapy is offered to patients it can have the most significant impact on treatment-wise, across cancer indications.
ProtectTrial stands for PROton versus photon Therapy for Esophageal Cancer – a Trimodality strategy. “This significant project has the potential to produce high-quality clinical data on the benefits of proton therapy. 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,” said Olivier Legrain, chief executive officer of IBA, in a statement.
The trial is the first European particle research project to consist of both public and private members. Included are 12 proton therapy centers, 17 academic partners, two leading industry partners and more than 30 clinical trial sites across eight countries. The trial will be carried out at Aarhus University in Denmark and headed by professor Cai Grau.
For esophageal cancer, the trial will assess the benefits of proton therapy in a trimodality treatment of radiotherapy, chemotherapy and surgery. This strategy will compare the clinical outcomes of PT and state-of-the-art photon radiotherapy for locally advanced esophageal cancer. The aim is to produce data that can help form European guidelines on the use of PT for the disease, which has a relatively high occurrence rate and requires complex multi-modality treatment. It also has significant morbidity.
The researchers will also create a new consensus model to help doctors across Europe select and refer patients with a variety of cancer indications who are most likely to benefit from proton therapy treatment.
“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,” said Professor Karin Haustermans, from Katholieke Universiteit Leuven (KUL), co-principal investigator of ProtectTrial.
Randomized trials are important for assessing the clinical benefits, side effects and survival outcomes of proton therapy in patients but face a number of challenges
. This is especially true in the U.S., where the biggest barrier is insurance, with many payers unwilling to cover proton therapy for patients and thereby preventing them from taking part in trials.
Additionally, resistance from various international authorities to reimburse providers for PT has contributed to cost barriers
, which in turn has led to demand for new proton therapy systems to be cut in half, according to MEDraysintell’s Proton Therapy World Market Report & Directory. It says that at least 10% of external radiotherapy patients could benefit from proton therapy. This would require some 2,800 particle therapy treatment rooms to be installed worldwide and could help propel demand.
"Proton therapy, like any business in the medical field, is directly affected by reimbursement policies, which differ in each country or region worldwide. Generally, countries that have a proton therapy center have a reimbursement policy for proton therapy implemented by their national health insurance system and/or covered by private insurances,” Paul-Emmanuel Goethals, co-founder of MEDraysintell, told HCB News in March.
Funding for ProtectTrial will be provided by Innovative Medicines Initiative (IMI), EFPIA, IBA and Varian, a Siemens Healthineers company. “We are especially pleased to contribute with AI-driven solutions and cloud-based infrastructure to the consortium,” said Kolleen Kennedy, president of the proton solutions and growth office at Varian.
Also playing a role in the project will be existing networks of the European Particle Therapy Network (EPTN) and the European Society for Radiotherapy and Oncology (ESTRO).
The trial is expected to be completed in 2027.