NEOadjuvant Trial in Adenocarcinoma of the oEsophagus and oesophagoGastric Junction International Study (Neo-AEGIS)

• Status: Active, not recruiting
• Trial end date: 1969-12-31

Summary

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.

• Phase: Phase 3

Details

• Lead Sponsor: Cancer Trials Ireland
• Collaborators: Centre Hospitalier Régional, Universitaire de Lille; Region H Rigshospitalet; Southampton Clinical Trials Unit
• Treatments: Albumin-Bound Paclitaxel; Capecitabine; Carboplatin; Cisplatin; Docetaxel; Epirubicin; Fluorouracil; Leucovorin; Oxaliplatin; Paclitaxel