A large-scale, randomised controlled clinical trial involving 400 patients will compare different radiotherapy treatments
Radiotherapy plays a key role in the treatment of many cancers. However, as conventional radiotherapy can cause side effects in surrounding organs, the dose is limited meaning that treatment takes longer and can be less effective. Proton therapy is an innovative form of radiotherapy. As the treatment is more focused on the tumour itself, a higher dose can be delivered while limiting damage to other, healthy organs, leading to shorter treatment for patients, and hopefully, better outcomes.
PROTECT-trial is a large-scale, multi-institutional, randomised controlled clinical trial with 19 industry and academic partners whose aim is to improve access to proton therapy for people with cancer of the oesophagus while helping validate the use of the therapy for cancer more widely. The PROTECT-trial project will compare the results of proton therapy and radiotherapy for people whose treatment also includes chemotherapy and surgery. The team will do this by carrying out a clinical trial involving 400 patients in 9 countries. Among other things, they will assess the impact of the two treatments on tumour control, survival, and the severity of side effects. If the results of the trial come out in favour of proton therapy, it could become a standard treatment option for patients with cancer of the oesophagus.
The hope is that with proton therapty, patients will recover faster and experience fewer side effects, dramatically improving their quality of life. The project will also provide evidence of the economic impacts of proton therapy, something which will help with health technology assessment (HTA) and reimbursement decisions in Europe. Although PROTECT-trial focuses on cancer of the oesophagus, the results will have implications for many other cancers where proton therapy could replace standard radiation therapy.
The partnership behind the PROTECT-trial engages 12 proton therapy centres, 17 academic partners, two leading industry partners and more than 30 clinical trial sites from eight countries, with a total funding pot of € 4 763 734.