STA:RTUPP: Second Time Around: Re-irradiation Treatment Using Photons or Protons. A Programme Development Grant to support a future Programme Grant

Background When a patient develops recurrent cancer or a new primary tumour in an anatomical area that has already received radiotherapy, re-irradiation, a second course of radiotherapy in a previously irradiated region, may be employed.

Re-irradiation offers improved local control, delayed use of surgery or systemic therapy and, in some patients, a second chance of cure. Re-irradiation may also come with increased risks of side-effects compared to a first course.

The problem is that there is no standardised approach to re-irradiation in any tumour site and so existing evidence is highly heterogeneous and generally of poor quality.

Many UK clinicians lack confidence in re-irradiation such that there is variation in the use of re-irradiation and not all who might benefit from re-irradiation receive it.

Additionally, the role of advanced radiotherapy technologies in re-irradiation, including Proton Beam Therapy (PBT), is uncertain. PBT, as opposed to standard photon radiotherapy, could reduce re-irradiation side-effects or improve tumour control. PBT is only available in two NHS centres, potentially requiring patients to travel further or relocate for treatment.

There is an urgent need for high-quality re-irradiation clinical trials, including investigation of PBT for re-irradiation. This requires a Programme Grant (PG).

Before proceeding to a PG, however, preliminary work is required to understand: numbers of patients currently receiving re-irradiation across different tumour sites and numbers of patients who could benefit from re-irradiation but who currently do not receive it. Additionally, patient, carer, clinician and commissioner perspectives on re-irradiation must be investigated.

Furthermore, expert teams must be assembled to contribute to the PG.

Aims: Within this Programme Development Grant (PDG), we aim to assess the unmet need for re-irradiation, from data and stakeholder perspectives, identify tumour sites suitable for study within the PG and assemble expert teams. Work Plan: Work will be performed over twelve months.

Theme 1: Patient numbers and eligibility Using routinely collected NHS cancer data we will determine current re-irradiation use across different tumours and estimate demand if re-irradiation were more widely adopted.

Theme 2: Patient and carer perspectives Through interviews and focus groups, we will explore patient and carer perspectives on re-irradiation, including the impact of PBT. A Patient and Public Involvement and Engagement (PPIE) team will be developed to embed PPIE throughout the PG.

Theme 3: Clinician and commissioner perspectives We will explore current uptake of, attitudes towards, and potential role of PBT for, re-irradiation through surveys and interviews.

Theme 4: Establishing a national multi-disciplinary re-irradiation team We will build a team of PPIE representatives, clinicians, radiotherapy physicists and methodologists to interpret outcomes from the above, identify tumour sites for further study within the PG and have leadership roles within this.

Theme 5: Preparing for high-quality re-irradiation delivery We will establish the team who will develop technical radiotherapy guidelines within the PG. Data to facilitate this will be sourced.

Impact: The above will shape the PG, which will include a multi-disease site clinical trial that investigates the role of PBT for re-irradiation. Ultimately this work will facilitate high-quality re-irradiation for NHS patients.