Title
Randomised Clinical Trial of neoadjuvant and adjuvant chemotherapy (Investigator’s choice Modified MAGIC or FLOT regimen) vs. neoadjuvant chemoradiation (CROSS protocol) in adenocarcinoma of the oesophagus and oesophago-gastric junction
Description
Patients with cT2-3 N0-3 M0 adenocarcinoma of the oesophagus or junction, based on clinical, CT-PET, and EUS staging, were randomised to the MAGIC/FLOT chemotherapy regimen versus the CROSS neoadjuvant chemoradiation protocol prior to surgery. Patients were randomised to either Arm A (Investigator’s choice Modified MAGIC or FLOT regimen of chemotherapy only and surgery) or Arm B (CROSS protocol: chemotherapy with radiation therapy and surgery as per multimodal protocol). For patients that were randomised to Arm A, the treating clinician was able to choose between the modified MAGIC or FLOT regimen as per their institution’s standard of care treatment.
Objectives
Primary Objective:
To evaluate 1, 2 and 3 year survival of patients treated with resection plus neoadjuvant and adjuvant chemotherapy, versus resection plus neoadjuvant chemo radiotherapy.
Secondary Objective(s):
To evaluate the effect of both neoadjuvant regimens on clinical and pathological response rate, tumour regression grade, surgical resection rate, node-positivity, post-operative pathology, disease-free survival and time to treatment failure.
Trial Design
Neo-AEGIS was a multicentre phase III open-labelled, randomised controlled trial. Eligible patients were randomised in a 1:1 fashion between the investigator’s choice of Modified MAGIC (ECF/ECX or EOF/EOX) or FLOT regimen, or the multimodality therapy (CROSS protocol) with a modernised design and delivery of radiation therapy.
Trial Status
Completed
Population
Willing patients eligible to consent must be male/female aged >18 years, have histologically verified adenocarcinoma of the oesophagus or oesophago-gastric junction based on OGD with adequate cardiac, respiratory, renal and liver functions.
Patients with advanced inoperable or metastatic oesophageal, junctional or gastric adenocarcinoma were deemed ineligible, along with patients with prior chemotherapy for gastrointestinal cancer and/or other malignancies within the last 5 years.
Contact Details
All trial enquiries should be sent to ctu@soton.ac.uk
Publications
NEOadjuvant trial in Adenocarcinoma of the oEsophagus and oesophagoGastric junction International Study (Neo-AEGIS). J V Reynolds, S R Preston, et al. ICORG 10-14: https://pubmed.ncbi.nlm.nih.gov/28578652/
Neo-AEGIS (Neoadjuvant trial in Adenocarcinoma of the Esophagus and Esophago-Gastric Junction International Study): Preliminary results of phase III RCT of CROSS versus perioperative chemotherapy (Modified MAGIC or FLOT protocol). Oral abstract presentation at the American Society of Clinical Oncology (ASCO) Annual Meeting, June 2021. ASCO abstract #4004.
Other Media
Preliminary results for international oesophageal cancer trial (Neo-AEGIS presented at ASCO 2021)
Funder
This trial was funded in the UK by Cancer Research UK (award reference no. C49462/A18483)