Welcome
Support Centre
22 July 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
A phase II/III randomised trial comparing Epirubicin, Cisplatin and Protracted Venous Infusion (PVI) 5-Fluorouracil (5-FU) (ECF), Epirubicin, Oxaliplatin and PVI 5-FU (EOF), Epirubicin, Cisplatin and Capecitabine (ECX) and Epirubicin, Oxaliplatin and Capecitabine (EOX) in Patients with Advanced Oesophago-Gastric Cancer
ISRCTN ISRCTN51678883
DOI 10.1186/ISRCTN51678883
ClinicalTrials.gov identifier
EudraCT number
Public title A phase II/III randomised trial comparing Epirubicin, Cisplatin and Protracted Venous Infusion (PVI) 5-Fluorouracil (5-FU) (ECF), Epirubicin, Oxaliplatin and PVI 5-FU (EOF), Epirubicin, Cisplatin and Capecitabine (ECX) and Epirubicin, Oxaliplatin and Capecitabine (EOX) in Patients with Advanced Oesophago-Gastric Cancer
Scientific title
Acronym The REAL-2 Study
Serial number at source MREC 01/2/31
Study hypothesis To compare overall and progression free survival in patients treated with these four regimens principally comparing PVI 5FU versus Capecitabine and also Cisplatin versus Oxaliplatin. The aim is to demonstrate non-inferiority between these two main comparisons.
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment United Kingdom
Disease/condition/study domain Advanced, oesophageal, oesophago-gastric junctional and gastric cancers.
Participants - inclusion criteria 1. Histologically verified locally advanced or metastatic adenocarcinoma, squamous cell carcinoma or undifferentiated carcinoma of the oesophagus, oesophago-gastric junction, or stomach. Patients with positive resection margin or tumour within 1mm of resection margin are eligible.
2. Uni-dimensionally measurable disease, as assessed by computed tomography (CT) and magnetic resonance imaging (MRI) scan in accordance with the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines; evaluable disease, for example on oesophagogastroscopy. The only exception is patients with positive or close resection margins who will be evaluated for survival only.
3. No prior chemotherapy
4. No prior radiotherapy other than adjuvant where relapse is outside the radiotherapy fields
5. A glomerular filtration rate (GFR) of ≥60 ml/min by EDTA clearance or 24 hour urinary creatinine, investigator’s discretion. Normal serum creatinine.
6. Serum bilirubin <2 x instiutional upper limit of normal range (IULNR)
7. Patients should have a projected life expectancy of at least 3 months
8. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2
9. No history of other malignant diseases other than adequately treated non-melanotic skin cancer or in situ carcinoma of the uterine cervix
10. Adequate bone marrow function, white blood cell count (WBC) >3 x 10^9/l, neutrophils >1.5 x 10^9/l, platelets >100 x 10^9/l
11. Written informed consent
Participants - exclusion criteria 1. Medical or psychiatric condition impairing the ability to give informed consent
2. Uncontrolled angina pectoris, heart failure, clinically significant uncontrolled cardiac arrhythmias, or clinically significant abnormal electrocardiogram (ECG) or cardiac history having a left ventricular ejection fraction (LVEF) of lower limit of normal range for institution as determined by multiple gated acquisition (MUGA) scan or echocardiogram
3. Any other serious uncontrolled medical conditions
4. Any pregnant or lactating woman. Any woman of child bearing potential must have a pregnancy test prior to randomisation and must take adequate precautions to prevent pregnancy during treatment. Any man with a partner of child bearing potential must take adequate precautions to prevent pregnancy during treatment.
5. Inability to complete the quality of life questionnaire
Anticipated start date 03/03/2000
Anticipated end date 14/11/2005
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 1000
Interventions Treatment should commence within 28 days of baseline CT scan and may continue for up to 24 weeks with a maximum of 8 cycles of epirubicin, cisplatin or oxaliplatin.

Patients are randomised to receive: 1. ECF Regimen (5-FU, Epirubicin and Cisplatin)
2. EOF Regimen (5-FU, Epirubicin and Oxaliplatin)
3. ECX Regimen (Capecitabine, Epirubicin and Cisplatin)
4. EOX Regimen (Capecitabine, Epirubicin and Oxaliplatin)
Primary outcome measure(s) The primary endpoint of the study is overall survival. The study is powered to demonstrate non-inferiority of the 2 x 2 comparisons.
Secondary outcome measure(s) 1. Response Rates
2.Toxicity
3. Duration of response and progression free survival
4. Quality of life
5. In the phase I part of the study, to establish the optimal dose of capecitabine in the regimens
Sources of funding Prof Cunningham's Clinical Research Fund
Roche Pharmaceuticals Research Grant
Sanofi-Aventis Research Grant
Trial website
Publications 1. 2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15928658
2. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18172173
Contact name Prof  David  Cunningham
  Address Royal Marsden Hospital
Downs Road
  City/town Sutton, Surrey
  Zip/Postcode SM2 5PT
  Country United Kingdom
  Tel +44 (0)20 8661 3156
  Fax +44 (0)20 8643 9414
  Email david.cunningham@rmh.nhs.uk
Sponsor The Royal Marsden NHS Foundation Trust (UK)
  Address Downs Road
  City/town Sutton
  Zip/Postcode SM2 5PT
  Country United Kingdom
  Tel +44 (0)20 8661 3156
  Fax +44 (0)20 8643 9414
  Email
  Sponsor website: http://www.royalmarsden.nhs.uk/home
Date applied 15/10/2002
Last edited 30/05/2012
Date ISRCTN assigned 15/10/2002
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.