REAL3 Trial of Efficacy of EOX With/Without Panitumumab in Previously Untreated Adv OG Cancer (REAL3)
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ClinicalTrials.gov Identifier: NCT00824785 |
Recruitment Status :
Terminated
(Lack of efficacy)
First Posted : January 19, 2009
Last Update Posted : December 11, 2012
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Sponsor:
Royal Marsden NHS Foundation Trust
Information provided by (Responsible Party):
Professor David Cunningham, Royal Marsden NHS Foundation Trust
Tracking Information | ||||
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First Submitted Date ICMJE | January 16, 2009 | |||
First Posted Date ICMJE | January 19, 2009 | |||
Last Update Posted Date | December 11, 2012 | |||
Study Start Date ICMJE | May 2008 | |||
Estimated Primary Completion Date | February 2013 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Overall survival [ Time Frame: Early termination ] Study closed early due to lack of efficacy
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Original Primary Outcome Measures ICMJE |
Overall survival: defined as the time from randomisation to the time of death due to any cause | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
response rate, toxicity, quality of life and PFS [ Time Frame: Early termination ] Study closed early due to lack of efficacy
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Original Secondary Outcome Measures ICMJE |
response rate evaluated by RECIST criteria progression free survival: defined as the date of randomisation until a progression event occurs | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | REAL3 Trial of Efficacy of EOX With/Without Panitumumab in Previously Untreated Adv OG Cancer | |||
Official Title ICMJE | 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 | |||
Brief Summary | 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. | |||
Detailed Description | Multicentre phase III, open labelled, randomised controlled trial. Randomisation will be 1:1 Arm A EOX and Arm B EOX + panitumumab. There will be a pilot phase II study of which the first 200 patients will be randomised and the primary endpoint for interim analysis will be when these patients have completed 6 months follow-up | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 3 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE | Oesophago-gastric Cancer | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Terminated | |||
Actual Enrollment ICMJE |
574 | |||
Original Estimated Enrollment ICMJE |
730 | |||
Estimated Study Completion Date ICMJE | February 2013 | |||
Estimated Primary Completion Date | February 2013 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Note: Epidermal growth factor receptor (EGFR) positivity by immunohistochemistry will not be required for study entry. Slides obtained from previously collected paraffin embedded archived specimens will be collected centrally for EGFR staining. A multivariate analysis will then be performed to exclude any effects of EGFR status on outcome measures Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United Kingdom | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00824785 | |||
Other Study ID Numbers ICMJE | CCR3024 | |||
Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Current Responsible Party | Professor David Cunningham, Royal Marsden NHS Foundation Trust | |||
Original Responsible Party | Prof David Cunningham, Royal Marsden NHS Foundation Trust | |||
Current Study Sponsor ICMJE | Royal Marsden NHS Foundation Trust | |||
Original Study Sponsor ICMJE | Same as current | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Royal Marsden NHS Foundation Trust | |||
Verification Date | December 2012 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |