Oesophageal cancer Cancer
Conditions
Interventions
Current interventions as of 06/02/2026:
Eligible patients will be allocated by a computer devised programme into one of the treatment groups: A) a group receiving proton beam radiotherapy (PBT) or B)
Sponsors
University College London
Eligibility
Sex/Gender
All
Age
16 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. 16 years of age or older 2. Histologically confirmed diagnosis of oesophageal adenocarcinoma (OAC) or squamous cell carcinoma (OSCC) 3. Tumour of the thoracic oesophagus or gastroesophageal junction with distal maximum extension no more than 3 cm beyond the gastroesophageal junction 4. cT stage >=2 and/or cN stage >=0-2 defined by AJCC 8th edition 5. ECOG performance status 0–1 6. Suitable for and fit to receive curative neoadjuvant Chemoradiotherapy followed by surgery by an Upper GI MDT 7. Suitable for and fit to receive adjuvant Immunotherapy according to local guidelines 8. Adequate cardiovascular and respiratory function for surgery in the opinion of the surgical team within 4 weeks prior to randomisation 9. Willing and able to give written informed consent and able to comply with treatment and follow up schedule 10. Willing and able to undergo treatment at a PBT centre (i.e. UCLH or The Christie) if randomised to Proton Arm
Exclusion criteria
Exclusion criteria: 1. Metastatic disease or extensive nodal disease (N3). 2. Patients who have had previous treatment for invasive oesophageal carcinoma or gastro-oesophageal junction carcinoma (including Photo Dynamic Therapy or laser therapy for high grade dysplasia/carcinoma in-situ). 3. Patients with > 3cm mucosal extension of tumour into the stomach beyond the GOJ or where the superior extent is in the cervical oesophagus 4. Tumour length based on position: 4.1. Length of primary tumour >10 cm in thorax, or 4.2. >12 cm in the gastroesophageal junction or lower third of the oesophagus, or 4.3. Total length of disease (primary tumour and involved lymph nodes) length >14 cm for lower third tumours. 5. Patients with unstable angina, uncontrolled hypertension, cardiac failure or arrhythmia and other clinically significant cardiac disease. 6. Patients with an oesophageal stent (patients requiring a PEG/RIG/feeding jejunostomy for nutritional purposes ARE eligible). 7. No relevant co-morbidities, including Usual Interstitial Pneumonia (UIP) pulmonary fibrosis and connective tissue disorders. 8. History of other malignancy likely to interfere with the protocol treatment (e.g. patients with previously treated malignancy who have been disease-free for 3 years, 8.2. A history of treated non-melanoma skin cancer, 8.3. Successfully treated in situ carcinoma, 8.4. CLL in stable remission, or indolent prostate cancer requiring no or only anti-hormonal therapy. 9. Any other situation, which in the opinion of the local PI, makes the patient unsuitable for this trial. 10. Women who are pregnant or breastfeeding. 11. Patients unable to adhere to the contraception guidance in the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency and percentage of patients that experience severe post operative complications prior to or at the follow-up assessment 3 months after surgery measured using adverse event data entered on the database by sites which is graded using both the CTCAE and the Clavien Dindo Scale | — |
Secondary
| Measure | Time frame |
|---|---|
| Preliminary data on longer term efficacy outcomes following 1 year of adjuvant immunotherapy for patients that do not achieve pathologic complete response at surgery measured using survival data and the number and percentages of different types of disease recurrences | — |
Countries
England, United Kingdom, Wales
Outcome results
None listed