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 | https://doi.org/10.1186/ISRCTN51678883 |
| Secondary identifying numbers | MREC 01/2/31 |
- Submission date
- 15/10/2002
- Registration date
- 15/10/2002
- Last edited
- 30/05/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof David Cunningham
Scientific
Scientific
Royal Marsden Hospital
Downs Road
Sutton, Surrey
SM2 5PT
United Kingdom
| Phone | +44 (0)20 8661 3156 |
|---|---|
| david.cunningham@rmh.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | |
| Study acronym | The REAL-2 Study |
| Study objectives | 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. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Advanced, oesophageal, oesophago-gastric junctional and gastric cancers. |
| Intervention | 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) |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Phase II/III |
| Drug / device / biological / vaccine name(s) | Epirubicin, Cisplatin and 5-Fluorouracil (5-FU) (ECF), Epirubicin, Oxaliplatin and 5-FU (EOF), Epirubicin, Cisplatin and Capecitabine (ECX) and Epirubicin, Oxaliplatin and Capecitabine (EOX) |
| Primary outcome measure | 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 measures | 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 |
| Overall study start date | 03/03/2000 |
| Completion date | 14/11/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1000 |
| Key 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, investigators 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 |
| Key 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 |
| Date of first enrolment | 03/03/2000 |
| Date of final enrolment | 14/11/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Royal Marsden Hospital
Sutton, Surrey
SM2 5PT
United Kingdom
SM2 5PT
United Kingdom
Sponsor information
The Royal Marsden NHS Foundation Trust (UK)
Not defined
Not defined
Downs Road
Sutton
SM2 5PT
United Kingdom
| Phone | +44 (0)20 8661 3156 |
|---|---|
| Website | http://www.royalmarsden.nhs.uk/home |
"ROR" |
https://ror.org/0008wzh48 |
Funders
Funder type
Industry
Prof Cunningham's Clinical Research Fund
No information available
Roche Pharmaceuticals Research Grant
No information available
Sanofi-Aventis Research Grant
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 06/06/2005 | Yes | No | |
| Results article | results | 03/01/2008 | Yes | No |
