The CHARIOT Trial has officially received OCTRU Green Light approval. Churchill Hospital, Oxford will be the first recruiting site to open, following their local green light checks, and recruitment is expected to commence in November 2018. The trial will run across 5 UK sites.
CHARIOT is an interventional, phase I, open label, multicentre, 3-stage, schedule finding trial using time to event continual reassessment method (TiTE-CRM). This study will test the combination of a novel ATR inhibitor with radiotherapy or chemoradiotherapy in oesophageal cancer and other solid cancers in both palliative and definitive treatment. Stage A1 (M6620 + palliative radiotherapy) and A2 (M6620 + palliative chemotherapy (cisplatin/capecitabine)), both in patients with advanced inoperable oesophageal cancer, will run parallel to one another, followed by Stage B (M6620 in combination with cisplatin/capecitabine and radical radiotherapy) in patients with oesophageal tumours for radical chemoradiotherapy. Stage B will commence once sufficient data is collected from stages A1 and A2.
CHARIOT is sponsored by the University of Oxford, funded by CRUK (C43735/A20874) and Merck KGaA, and managed by the Oncology Clinical Trials Office (OCTO). Statistical support is provided by the Centre for Statistics in Medicine (CSM). The Chief Investigator is Professor Maria Hawkins.