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

PHASE3CompletedINTERVENTIONAL
Enrollment

377

Participants

Timeline

Start Date

January 24, 2013

Primary Completion Date

August 4, 2022

Study Completion Date

August 4, 2022

Conditions
Adenocarcinoma of the OesophagusAdenocarcinoma of the Oesophago-gastric JunctionOesophageal TumoursJunctional TumoursOesophageal 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

Trial Locations (29)

2100 København Ø

Rigshospitalet, Blegdamsvej 9

Unknown

Centre Hospitalier Régional, Universitaire de Lille 2 Avenue Oscar Lambret, 59000, Lille

Cork University Hospital, Cork

Beaumont Hospital, Dublin

SLRON- St Luke's Radiation Oncology Network, Dublin

St. James's Hospital, Dublin

University Hospital Galway, Galway

Karolinska Institutet and Karolinska University Hospital, Stockholm

BH7 7DW

The Royal Bournemouth Hospital, The Royal Bournemouth and Christchurch Hospitals NHS Foundation

CB2 0QQ

Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Box 279(s4), Cambridge Biomedical Camp

CF14 2TL

Velindre Cancer Centre, Velindre NHS Trust, Velindre Road, Whitchurch

CV2 2DX

University Hospitals Coventry & Warwickshire, Clifford Bridge Road, Walsgrave

HU16 5JQ

Hull and East Yorkshire Hospitals NHS Trust, Castle Hill Hospital,, Cottingham

PO6 3LY

Portsmouth Hospitals NHS Trust, Southwick Hill Road, Cosham

HA6 2RN

Mount Vernon Cancer Centre, E & N Hertfordshire NHS Trust, Rickmansworth Road, Northwood

HG5 1PB

Nottingham City Hospital, Nottingham University Hospitals NHS Trust, Hucknall Road

OX3 7LE

Oxford University Hospital NHS Trust Churchill Hospital, Headington

SO16 6YD

University Hospital Southampton NHS Foundation Trust, Southampton General Hospital, Division A Cancer Care, Mp307, T

GU2 7XX

Royal Surrey County Hospital, Guildford

WR5 1DD

Worcestershire Royal Hospital, Worcestershire Oncology Centre, Charles Hastings Way

BT9 7AB

Belfast Health and Social Care Trust, Northern Ireland Cancer Centre, Belfast CityHospital, Belfast

CH63 4JY

The Clatterbridge Cancer Centre NHS Foundation Trust, Birkenhead, Wirral

BS2 8ED

University Hospitals Bristol NHS Foundation Trust, Bristol

PL6 8DH

University Hospital Plymouth NHS Trust, Derriford Hospital, Derriford Road, Crownhill, Plymouth

EH4 2XU

NHS Lothian, Edinburgh Cancer Centre,, Edinburgh

G12 0YN

Beatson West of Scotland Cancer Centre, Glasgow, 1056 Great Western Road

W2 1NY

Imperial College Healthcare NHS Trust St Mary's Hospital, London

NE7 7DN

The Newcastle upon Tyne Hospital NHS Foundation TrustFreeman Hospital, Freeman Road, High Heaton, Newcastle upon Tyne

PR2

Royal Preston Hospital, Sharoe Garoo Lane, Fulwood, Preston

All Listed Sponsors
collaborator

Southampton Clinical Trials Unit

UNKNOWN

collaborator

Region H Rigshospitalet

UNKNOWN

collaborator

Centre Hospitalier Régional, Universitaire de Lille

UNKNOWN

lead

Cancer Trials Ireland

NETWORK

NCT01726452 - NEOadjuvant Trial in Adenocarcinoma of the oEsophagus and oesophagoGastric Junction International Study (Neo-AEGIS) | Biotech Hunter | Biotech Hunter