Lack of efficacy
REAL3
REAL 3 : A Randomised Open-labelled Multicentre Trial of the Efficacy of Epirubicin, Oxaliplatin and Capecitabine (EOX) With or Without Panitumumab in Previously Untreated Advanced Oesophago-gastric Cancer
Sponsor study identifier
interventional
574
1 country
7
Study Start
May 2008
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
To determine whether adding panitumumab, an antibody against the epidermal growth factor receptor (EGFR), to standard chemotherapy with epirubicin, oxaliplatin and capecitabine (EOX), improves the duration of survival of patients with advanced stomach and oesophageal cancer.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2008
Date type not reportedThis date has not been verified as actual or estimated.
January 16, 2009
Actual (reported)January 19, 2009
Actual (reported)February 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Overall survival
Study closed early due to lack of efficacy
Early termination
response rate, toxicity, quality of life and PFS
Early termination
EOX chemotherapy (epirubicin, oxaliplatin and capecitabine)
EOX chemotherapy with the addition of panitumumab 9mg/kg every 21 days
epirubicin 50mg/m(2) IV on day 1 oxaliplatin 130mg/m(2) IV on day 1 with hydration capecitabine 1250mg/m(2)/day PO in two divided doses continuously from days 1-21
epirubicin 50mg/m(2) IV on day 1 oxaliplatin 100mg/m(2) IV on day 1 with hydration capecitabine 1000mg/m(2)/day PO in two divided doses continuously from days 1-21 panitumumab -9 mg/kg every 21 days
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
epirubicin, oxaliplatin, capecitabine (EOX)
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordTreatment programme
EOX + panitumumab
The registry describes a treatment programme. Individual components, doses and actual administration are not established by this entry.
Bournemouth
Bournemouth, United Kingdom
St Luke's Guildford
Guildford, United Kingdom
Royal Liverpool
Liverpool, United Kingdom
Royal Marsden NHS Foundation Trust
London, SW3 6JJ, United Kingdom
Clatterbridge Oncology Centre
Metropolitan Borough of Wirral, United Kingdom
Newcastle
Newcastle, United Kingdom
Royal Marsden NHS Foundation Trust
Sutton, United Kingdom
Smyth EC, Vlachogiannis G, Hedayat S, Harbery A, Hulkki-Wilson S, Salati M, Kouvelakis K, Fernandez-Mateos J, Cresswell GD, Fontana E, Seidlitz T, Peckitt C, Hahne JC, Lampis A, Begum R, Watkins D, Rao S, Starling N, Waddell T, Okines A, Crosby T, Mansoor W, Wadsley J, Middleton G, Fassan M, Wotherspoon A, Braconi C, Chau I, Vivanco I, Sottoriva A, Stange DE, Cunningham D, Valeri N. EGFR amplification and outcome in a randomised phase III trial of chemotherapy alone or chemotherapy plus panitumumab for advanced gastro-oesophageal cancers. Gut. 2021 Sep;70(9):1632-1641. doi: 10.1136/gutjnl-2020-322658. Epub 2020 Nov 16.
Waddell T, Chau I, Cunningham D, Gonzalez D, Okines AF, Okines C, Wotherspoon A, Saffery C, Middleton G, Wadsley J, Ferry D, Mansoor W, Crosby T, Coxon F, Smith D, Waters J, Iveson T, Falk S, Slater S, Peckitt C, Barbachano Y. Epirubicin, oxaliplatin, and capecitabine with or without panitumumab for patients with previously untreated advanced oesophagogastric cancer (REAL3): a randomised, open-label phase 3 trial. Lancet Oncol. 2013 May;14(6):481-9. doi: 10.1016/S1470-2045(13)70096-2. Epub 2013 Apr 15.
Prof Cunningham, David
Royal Marsden NHS Foundation Trust
574 participants (actual enrollment reported by the registry).
First Submitted
January 16, 2009
First Posted
January 19, 2009
Study Start
May 2008
Date type not reportedThis date has not been verified as actual or estimated.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
February 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 11, 2012
Record last verified: 2012-12
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: