Condition category
Cancer
Date applied
18/02/2015
Date assigned
18/02/2015
Last edited
10/07/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

Additional identifiers

EudraCT number

2011-001858-28

ClinicalTrials.gov number

NCT01726452

Protocol/serial number

18094

Study information

Scientific title

Randomised clinical trial of neoadjuvant and adjuvant chemotherapy (MAGIC regimen)
 vs. 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

Topic: Cancer; Subtopic: Upper Gastro-Intestinal Cancer; Disease: Oesophagus, Stomach

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 measures

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

02/03/2022

Reason abandoned

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: 594; UK Sample Size: 378

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

02/03/2019

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

All Ireland Cooperative Oncology Research Group

Sponsor details

60 Fitzwilliam Square
Dublin 2
.
Ireland

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

Cancer Research UK

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes