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

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.

Conditions

• Adenocarcinoma of the Oesophagus
• Adenocarcinoma of the Oesophago-gastric Junction
• Oesophageal Tumours
• Junctional Tumours
• Oesophageal Cancer

Interventions

DRUG

Epirubicin

50mg/m2 on Day 1 of each cycle only (i.e. every 21 days)

DRUG

Cisplatin / Oxaliplatin

Cisplatin, 60mg/m2 on day 1 of each cycle only (i.e. every 21 days). OR Oxaliplatin,130 mg/m2 on Day 1 of each cycle (i.e. every 21 days) The choice between administering Cisplatin or Oxaliplatin is at the discretion of the investigator.

DRUG

5 Flourouracil/ Capecitabine

5-Flourouracil 200 mg/m2/day every day for 21 days OR Capecitabine 625 mg/m2 twice daily orally). The choice between administering 5 Flourouracil or Capecitabine is at the discretion of the investigator.

RADIATION

(41.4 Gy/23 fractions)

Patient will receive 4.5 weeks of radiation therapy (41.4 Gy/23 fractions).

DRUG

Paclitaxel

50mg/ m2 Paclitaxel dose administered on Days 1, 8, 15,22 and 29. Dexamethasone, Chlorphenamine and Ranitidine dose given per local standard practice. NACL infusion per local standard practice. Ondansetron dose given per local standard practice on Days 1, 8, 15, 22 and 29.

DRUG

Carboplatin

Dose determined as per calculation, infused on Days 1, 8, 15, 22 and 29

DRUG

Docetaxel

Docetaxel, 50 mg/m², day 1 of each cycle (i.e. every 14 days)

DRUG

Oxaliplatin

85 mg/m², day 1 of each cycle (i.e. every 14 days)

DRUG

Leucovorin

200 mg/m², day 1 of each cycle (i.e. every 14 days).

DRUG

5-Fluorouracil

2600 mg/m² Day 1 of each cycle (i.e. every 14 days) Dexamethasone or equivalent, 8mg, twice daily, Day before, day of and day after OR administered as per standard practice

Sponsors & Collaborators

• Southampton Clinical Trials Unit

  collaborator UNKNOWN

• Region H Rigshospitalet

  collaborator UNKNOWN

• Centre Hospitalier Régional, Universitaire de Lille

  collaborator UNKNOWN

• Cancer Trials Ireland

  lead NETWORK

Principal Investigators

• John V. Reynolds, Professor · Trinity Centre, St. James's Hospital, Dublin 8, Ireland

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-01-24

Primary Completion

2022-08-04

Completion

2022-08-04

Countries

• Denmark
• France
• Ireland
• Sweden
• United Kingdom

Study Locations