NEOadjuvant Trial in Adenocarcinoma of the oEsophagus and oesophagoGastric Junction International Study (Neo-AEGIS)
NCT01726452
Interventional
Phase 3
Active, not recruiting
This is a multicentre phase III open-labelled, randomised controlled trial. Eligible patients
will be randomised in a 1:1 fashion between neoadjuvant and adjuvant chemotherapy
(Investigator's choice modified MAGIC (ECF/ECX or EOF/EOX) or FLOT regimen) and surgery or
Arm B (CROSS protocol: chemotherapy with radiation therapy and surgery as per multimodal
protocol). Primary Objective: To evaluate one, two and three 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 (in particular relief of dysphagia, improvement in health related quality of life
(HRQL), endoscopic regression, and CT-PET evidence of tumour response), tumour regression
grade, node-positivity, post-operative pathology, disease-free survival, time to treatment
failure, toxicity, post-operative complications and Health Related Quality of Life (HRQL). Exploratory Objective(s): Translational Research: The collection of blood and tissue samples for storage in the bio
bank for future research.
Aug 31,2012
All
18 Years
N/A
18 Years
N/A
377