Contact information
Type
Scientific
Primary contact
Dr Neo-AEGIS Coordinator
ORCID ID
Contact details
Clinical Trials Unit
MP 131
Tremona Road
Southampton
SO16 6YD
United Kingdom
-
neoaegis@soton.ac.uk
Additional identifiers
EudraCT number
2011-001858-28
ClinicalTrials.gov number
NCT01726452
Protocol/serial number
18094
Study information
Scientific title
Neo-AEGIS (NEO-adjuvant trial in Adenocarcinoma of the oEsophagus and oesophagoGastric junction International Study): Randomised Clinical Trial of neoadjuvant and adjuvant chemotherapy (Investigator’s choice of Modified MAGIC or FLOT regimen) versus neoadjuvant chemoradiation (CROSS protocol) in adenocarcinoma of the oesophagus and oesophago-gastric junction
Acronym
Neo-AEGIS
Study hypothesis
The primary objective is to compare two level-1 evidence based approaches to adenocarcinoma of the oesophagus and oesophago-gastric junction. The MAGIC study included a minority of patients with oesophageal and junctional tumours and staging and QA modalities did not encompass current standards. The CROSS trial was not specific to adenocarcinoma, and compared a multimodal regimen to surgery alone.
Ethics approval
NRES Committee East Midlands – Leicester, 18/12/2014, ref: 14/EM/1284
Study design
Randomised; Interventional; Design type: Process of Care, Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a patient information sheet
Condition
Adenocarcinoma of the oesophagus and oesophago-gastric junction
Intervention
1. Chemotherapy: ECX/ECF or EOX/EOF v Paclitaxel/Carboplatin given concurrently with radiotherapy
2. Radiotherapy: Concurrently with paclitaxel/carboplatin chemotherapy pre-surgery
3. Surgery: Following neoadjuvant treatment
Intervention type
Other
Phase
Phase III
Drug names
Primary outcome measure
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 outcome measures
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.
Overall trial start date
01/08/2014
Overall trial end date
31/12/2023
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Histologically verified adenocarcinoma of the oesophagus or oesophagogastric junction based on OGD
2. CT- 18FDG-PET in all patients and EUS, if feasible
3. Staging laparoscopy will be performed for tumours of the abdominal oesophagus, junction and
proximal stomach i.e. AEG II and AEG III (at the investigator's discretion)
4. Pre-treatment stage cT2-3, N0-3, M0
5. No prior abdominal or thoracic radiotherapy
6. Male/female patients aged >18 years
7. ECOG Performance Status 0, 1 or 2
8. ASA Grading I-II
9. Adequate cardiac function. For patients with a significant cardiac history (e.g. known ischaemic disease, cardiomyopathy) an ejection fraction >50% and cardiac clearance
by a consultant cardiologist for major surgery and cancer therapies is required, if clinically indicated.
Where necessary, the Chief Investigator should be consulted to discuss the patient's eligibility.
10. Adequate respiratory function. Patients should have pulmonary function tests completed with FEV1 >1.5L
11.Adequate bone marrow function: absolute neutrophil count (ANC) >1.5x109/l; white blood cell count >3x109/l; platelets >
100x109/l; haemoglobin (Hb) >9g/dl (can be post-transfusion).
12.Adequate renal function: glomerular filtration rate >60ml/minute calculated using the Cockcroft-Gault Formula
13.Adequate liver function: serum bilirubin <1.5x ULN; AST <2.5x ULN and ALP <3x ULN (ULN as per institutional standard)
14. Written informed consent must be obtained from the patient before any study specific procedures are performed
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Planned Sample Size: 540; UK Sample Size: 250
Participant exclusion criteria
1. Tumours of squamous histology
2. Patients with advanced inoperable or metastatic oesophageal, junctional or gastric adenocarcinoma
3. Any prior chemotherapy for gastrointestinal cancer
4. Prior abdominal or thoracic radiation
5. Patients who are unfit for surgery or cancer treatments based on cardiac disease
6. Clinical COPD with significant obstructive airways disease classified by FEV1 < 1.5 L or PaO2 less than 9kPa on room air
7. Known peripheral neuropathy >Grade 1 (absence of deep tendon reflexes as the sole neurological abnormality does not render the patient ineligible)
8. Known positive tests for human immunodeficiency virus (HIV) infection, acute or chronic active hepatitis B infection
9. Any other malignancies within the last 5 years (other than curatively treated basal cell carcinoma of the skin and/or in situ carcinoma of the cervix)
Recruitment start date
02/03/2015
Recruitment end date
31/12/2020
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Royal Surrey County Hospital (lead site)
Egerton Road
Guildford
Surrey
GU2 7XX
United Kingdom
Trial participating centre
Queen Elizabeth Medical Centre
Edgbaston
Birmingham
B15 2TH
United Kingdom
Trial participating centre
Bristol Haematology and Oncology Centre
Horfield Road
Bristol
BS2 8ED
United Kingdom
Trial participating centre
Freeman Hospital
Freeman Road
High Heaton
Newcastle Upon Tyne
Tyne and Wear
NE7 7DN
United Kingdom
Trial participating centre
Royal Infirmary of Edinburgh
51 Little France Crescent
Edinburgh
EH16 4SA
United Kingdom
Trial participating centre
Addenbrooke’s Hospital
Hills Road
Cambridge
CB2 0QQ
United Kingdom
Trial participating centre
Oxford Cancer and Haematology Centre
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LE
United Kingdom
Trial participating centre
St Mary’s Hospital
Praed Street
Paddington
London
W2 1NY
United Kingdom
Sponsor information
Organisation
Cancer Trials Ireland
Sponsor details
Innovation House
Old Finglas Road
Dublin
D11 KXN4
Ireland
-
no@email.provided
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Cancer Research UK
Alternative name(s)
Funding Body Type
unknown
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
All information relating to this study or investigational agent, and not previously published, is considered confidential and proprietary. This confidential information shall remain the sole property of ICORG and shall not be disclosed or used (except in the performance of this study) without prior written authorisation.
IPD sharing statement
Trial data are provided to the Neo-AEGIS DSMB and will be used in trial publications, however individual patient data will not be provided to external groups on request. The trial data are held at the HRB Clinical Research Facility in Galway, Ireland: http://www.nuigalway.ie/hrb_crfg/
Intention to publish date
01/01/2024
Participant level data
Not expected to be available
Basic results (scientific)
Publication list