Randomised Clinical Trial of Neoadjuvant and Adjuvant Chemotherapy (MAGIC Regimen) vs. Neoadjuvant Chemoradiation (CROSS Protocol) in Adenocarcinoma of the Oesophagus and Oesophago-gastric Junction
Patients with cT2-3 N0-1 M0 adenocarcinoma of the oesophagus or junction, based on clinical,
CT-PET, and EUS staging, will be randomised to the MAGIC chemotherapy regimen versus the
CROSS neoadjuvant chemo radiation protocol prior to surgery. Patients will be randomised to
either Arm A (MAGIC regimen of chemotherapy only and surgery) or Arm B (CROSS protocol:
chemotherapy with radiation therapy and surgery as per multimodal protocol).
Eligible patients will be randomised in a 1:1 fashion between the MAGIC regimen or the CROSS
Exploratory Study- Translational Research :
All patients enrolled in this trial, will be invited to consent to having some of their
tissue and blood taken for use in future research studies. Following consent from the
patient, tissue biopsy of tumour and/or normal oesophageal tissue will be obtained for
research at the same time as that biopsied for histological diagnosis. In addition, tumour
and/or normal tissue will also be obtained following surgical resection. Patient blood
samples will also be obtained, both before and during treatment. The identification of both
tumour and circulating biomarkers will increase knowledge of the molecular mechanism(s)
underlying treatment response in oesophageal cancer and may facilitate the identification of
biomarkers predicting patient response to treatment.
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Overall survival will be calculated from the date of randomisation and an event registered on the date of death from any cause. Patients lost to follow up, or those with no death recorded on the day the database is frozen, will be censored on the date of last follow up.
At end of trial- up to 3 years in follow up
John V. Reynolds, Professor
Trinity Centre, St. James's Hospital, Dublin 8
Ireland: Irish Medicines Board