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Proton versus photon therapy for oesophageal cancer - a trimodality strategy

 

For full details of this topic, please see the topic text and webinars on the IMI website.

The main objective of this topic is to examine the value of proton therapy as a treatment modality through a clinical study in oesophageal cancer. The study will compare outcomes between pencil-beam scanning proton therapy and intensity-modulated radiation therapy (IMRT). The study will determine if proton therapy in a trimodality (radiotherapy-chemotherapy-surgery) treatment;

(i) reduces treatment-related cardio-pulmonary toxicity;

(ii) increases loco-regional tumour control and pathological complete response and the influence of dose escalation;

(iii) improves disease-free and overall survival.

Oesophageal cancer is chosen due to its relatively high occurrence in the population and the possibility to extend findings to other cancer types.

A second objective is to use the evidence generated during the oesophageal cancer study to reach a consensus on which methodology is most suitable to evaluate PT treatment for other indications. To facilitate this objective, cost-effectiveness data should be collected during the duration of the action. This objective should be supported by engaging with selected stakeholders as advisors such as the broader oncology community including oncologists (e.g. through relevant European networks), healthcare providers, health technology assessment (HTA) agencies, payers, and patient associations. In addition, the findings of the proposed project should be disseminated via publications, presentations at relevant conferences, and other suitable dissemination methods.

For full details of this topic, please see the topic text and webinars on the IMI website.

Alongside chemotherapy and surgery, radiotherapy (RT) has evolved to become one of the essential therapies for the treatment of cancer. However, radiotherapy is not suitable for all cancer types, and when used, the potential for negative side effects to surrounding organs can limit the dose administered leading to longer treatment times and reduced effectiveness. By delivering a high radiation dose, more precisely focused on the tumour site, proton therapy (PT) has the potential to reduce these adverse events and provide better outcomes for cancer patients.

Although the number of patients treated annually with PT is increasing, the clinical evidence supporting its effectiveness remains limited due to the lack of large multi-centre studies. There is a critical need for high quality evidence from multi-centre trials to determine the potential role of PT for various cancer indications and to allow a consensus to be reached across Europe on the most suitable indications.

A robust evidence base on the effectiveness of PT has the potential to open a new treatment modality for cancers with currently very low survival rates, for example oesophageal cancer. Oesophageal cancer is the seventh most common cancer worldwide, with more than 570 000 new cases per year leading to more than 500 000 cancer deaths annually. Until recently, surgery was the main treatment for patients with localised disease. In 2012, the results of the Chemoradiotherapy for Oesophageal Cancer Followed by Surgery Study (CROSS) randomised trial demonstrated that adding neoadjuvant chemo-radiation to surgery results in a beneficial effect on pathological complete response (pCR) and survival compared to surgery alone. However, with a pCR of 30 % and a five-year overall survival rate of 45-50 %, there is still a large unmet need.

The unique properties of PT allow oesophageal cancer patients the opportunity to receive more conformal radiotherapy with the possibility of reducing the dose to the surrounding normal organs including the lungs, heart and liver. Treatment of oesophageal cancer patients with PT is under evaluation by several institutions. Recent publications present the role and the potential benefits PT offers to those patients and could lead to better patient outcomes. Nevertheless, none of those publications provide level 1 evidence.

To build a robust evidence base to assess the potential of PT in oesophageal and other cancers, multi-centre international trials have to take place. The current diversity of reimbursement and coverage policies across the EU makes these trials difficult. A public-private collaboration of proton therapy oncologists, treatment centres, software developers and equipment manufacturers is needed to define a methodology to conduct clinical trials in PT at a European scale. In addition, a key factor is the generation of robust clinical evidence which is neutral and unbiased. A clinical trial conducted in a European framework, in a collaboration between industry and public partners, has an inherent degree of independence and neutrality required by the highest standards of clinical research.

For full details of this topic, please see the topic text and webinars on the IMI website.

In their proposals, applicants should describe how the outputs of the project will contribute to the following impacts and include wherever possible baseline, targets and metrics to measure impact:

  • The outcome of this research is potentially practice-changing as it may define a new and improved standard for the treatment of oesophageal cancer patients and potentially patients with other cancer indications.
  • The morbidity data from the study will allow better understanding of the dose-volume relationships for normal tissue complications, enabling refined selection of patients for proton therapy in the future.
  • The results should allow health authorities and healthcare providers to improve the quality of care through better evidence of benefits and patient outcomes and support reimbursement decisions.

In their proposals, applicants should outline how the project plans to leverage the public-private partnership model to maximise impacts on innovation, research & development; regulatory, clinical and healthcare practices, as relevant. This could include a strategy for the engagement with patients, healthcare professional associations, healthcare providers, regulators, HTA agencies, payers, etc., where relevant. An advisory group including these stakeholders should be set up.

In their proposals, applicants should outline how the project will:

  • Manage research data including use of data standards.
  • Disseminate, exploit, and sustain the project results. This may involve engaging with suitable biological and medical sciences research infrastructures.

Communicate the project activities to relevant target audiences.