A randomised phase 2 trial comparing proton versus photon-based neoadjuvant chemoradiation, followed by adjuvant immunotherapy, in oesophageal cancer

niversity College London0 sites170 target enrollmentFebruary 15, 2024

Overview

No summary available.

Registry

who.int

Start Date

February 15, 2024

End Date

June 1, 2032

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

niversity College London

•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

•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\. Total length of disease (primary tumour and involved lymph nodes) length \> 8 cm
•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 \< 1 year, or patients with active malignancy undergoing treatment). Exceptions:
•8\.1\. Subjects who have been successfully treated and disease\-free for \> 3 years,
•8\.2\. A history of treated non\-melanoma skin cancer,