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22 May 2012
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| 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 |
| ClinicalTrials.gov identifier | |
| 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 | |
| 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 | |
| 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 |
| 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 |
| Sponsor website: | http://www.royalmarsden.nhs.uk/home |
| Date applied | 15/10/2002 |
| Last edited | 03/11/2010 |
| Date ISRCTN assigned | 15/10/2002 |
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| © 2012 ISRCTN unless otherwise stated. | |
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