PROTIEUS
Research type
Research Study
Full title
A Randomised Phase 2 Trial Comparing Proton versus Photon Based Neoadjuvant Chemoradiation, followed by Adjuvant Immunotherapy, in Oesophageal Cancer.
IRAS ID
329646
Contact name
Natasha Hava
Contact email
Sponsor organisation
University College London
ISRCTN Number
ISRCTN50098578
Duration of Study in the UK
5 years, 2 months, 1 days
Research summary
Although the optimal treatment strategy in oesophageal (food pipe) cancer has been the subject of research for several decades, overall outcomes are very poor, with 15% 5-year survival. In the UK there are 9100 new cases of oesophago-gastric cancer diagnosed and approximately 7925 deaths every year (CRUK Oct 2019). Oesophageal cancer is a strategic priority for CRUK and a serious health problem world-wide. Pre-surgery treatment consists of chemotherapy or chemoradiation, but the optimal treatment is unknown. Over 60% patients experience severe side-effects from their treatment and this impacts their outcomes. Proton beam therapy (PBT) is a new radiotherapy treatment; there are currently only 2 centres in England with Proton beam therapy machines. Proton beam therapy may help to reduce side-effects and is an important avenue of research. This trial has been funded by CRUK.
This study aims to investigate if PBT and chemotherapy given before surgery for oesophageal cancer significantly reduces the risk of severe toxicity and prevents delay of post-operative immunotherapy when compared with standard photon radiotherapy.
This is a phase II, randomised controlled trial. Patients over 16 years with resectable oesophageal cancer will be randomised 1:1 into the experimental arm (PBT, chemotherapy + surgery) and control arm (photon radiotherapy, chemotherapy + surgery). Patients with tumour cells remaining after surgery that are suitable for immunotherapy will then receive up to 12 months of treatment as per standard of care. Patients with complete response after surgery will have the option of additional chemotherapy as standard of care. This UK trial will recruit patients from 15 NHS sites; all patients randomised to receive PBT will be treated at UCLH/Christie. Patients will be followed up at NHS sites for up to 1 year, and then survival data will be collected from NHS Digital for a further 2 years.REC name
London - Camden & Kings Cross Research Ethics Committee
REC reference
23/LO/0964
Date of REC Opinion
23 Jan 2024
REC opinion
Further Information Favourable Opinion