A Randomised Phase 2 Trial Comparing Proton versus Photon Based Neoadjuvant Chemoradiation, followed by Adjuvant Immunotherapy, in Oesophageal Cancer
Trial Summary:
The PROTIEUS trial is a Phase 2 randomised controlled study comparing proton beam therapy (PBT) and photon-based chemoradiotherapy (CRT) in the treatment of resectable oesophageal cancer. The trial aims to determine whether concurrent PBT with chemotherapy reduces severe post-operative complications (grade 3 or higher) within 90 days of surgery, compared to photon CRT. Secondary endpoints include pathologic complete response rates, disease-free survival, overall survival, toxicity, quality of life, and cost-effectiveness. The trial will recruit 170 patients (130 with adenocarcinoma and 40 with squamous cell carcinoma) across 10-15 sites. Patients will receive neoadjuvant CRT followed by surgery, with adjuvant immunotherapy for those with residual disease. The trial also includes exploratory studies on biomarkers and the impact of PBT on cardiovascular health. An observational sub-study will assess reasons for non-participation. Patients will be followed for up to 3 years.
RT QA Summary
All QA activity will be streamlined with previous trial QA, where applicable. Please contact the RTTQA Group directly using the contact details below to discuss.
| QA Process | QA Activity | Required for Trial | Additional Details |
|---|---|---|---|
| Pre-Accrual | Facility Questionnaire |  | |
| Outlining Benchmark Case | | 1 Case | |
| Planning Benchmark Case | | 1 Case + 1 Distal Case for Proton Centres | |
| Dummy Run | |||
| During Accrual | Individual Case Review | | Prospective: First three (outlining) and first (planning) recruited photon patients at each centre. First three recruited photon patients at each PBT centre. Retrospective: All photon and proton patients, outlining and planning. |
| Data collection | | Brief clinical history, diagnostic reports (EUS, CT, PET/CT), full planning data including CT images, structure set, plan and dose cube and completed plan assessment form (PAF) | |
| Dosimetry | | ||
| QA Streamlining | | SCOPE2 |
RTTQA Contact: protieus.rttqa@wales.nhs.uk
Chief Investigator: Professor Maria Hawkins
RT Lead: Ganesh Radhakrishna
Sponsor: University College London ctc.protieus@ucl.ac.uk
Funder: Cancer Research UK, Taylor Family Foundation