History of Changes for Study: NCT00824785

REAL 3 Version 1.3: Trial of the Efficacy of Epirubicin, Oxaliplatin and Capecitabine (EOX) With or Without Panitumumab in Previously Untreated Advanced Oesophago-Gastric Cancer (REAL 3)

Latest version (submitted December 10, 2012) on ClinicalTrials.gov

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Study Record Versions

Version	Submitted Date	Changes
1	January 16, 2009	None (earliest Version on record)
2	October 27, 2009	Contacts/Locations, Outcome Measures, Study Status, Study Identification, Eligibility, Arms and Interventions and Conditions
3	November 3, 2009	Contacts/Locations, Arms and Interventions, Outcome Measures and Study Status
4	December 10, 2012	Recruitment Status, Sponsor/Collaborators, Study Status, Outcome Measures, Contacts/Locations, Study Design, Study Identification and Arms and Interventions

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Study NCT00824785
Submitted Date: January 16, 2009 (v1)

Study Identification


Unique Protocol ID:	CCR3024
Brief Title:	REAL 3 Version 1.3: Trial of the Efficacy of Epirubicin, Oxaliplatin and Capecitabine (EOX) With or Without Panitumumab in Previously Untreated Advanced Oesophago-Gastric Cancer (REAL 3)
Official Title:	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
Secondary IDs:

Study Status


Record Verification:	January 2009
Overall Status:	Recruiting
Study Start:	May 2008
Primary Completion:	February 2013 [Anticipated]
Study Completion:	February 2013 [Anticipated]

First Submitted:	January 16, 2009
First Submitted that Met QC Criteria:	January 16, 2009
First Posted:	January 19, 2009 [Estimate]

Last Update Submitted that Met QC Criteria:	January 16, 2009
Last Update Posted:	January 19, 2009 [Estimate]

Study Description


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 Design


Study Type:	Interventional
Primary Purpose:	Treatment
Study Phase:	Phase 3
Interventional Study Model:	Parallel Assignment
Number of Arms:	2
Masking:	None (Open Label)
Allocation:	Randomized
Enrollment:	730 [Anticipated]

Arms and Interventions

Arms

Assigned Interventions

Active Comparator: Arm A EOX

EOX chemotherapy (epirubicin, oxaliplatin an capecitabine)

Drug: epirubicin, oxaliplatin, capecitabine, panitumumab

EOX chemotherapy will last 21 days and consist of the following:

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 (Arm A) capecitabine 1000mg/m(2)/day PO in two divided doses continuously from days 1-21 (Arm B)

panitumumab -9mg/kg every 21 days

Active Comparator: Arm B EOX + panitumumab.

Chemotherapy with the addition of panitumumab 9mg/kg every 21 days

Drug: epirubicin, oxaliplatin, capecitabine, panitumumab

EOX chemotherapy will last 21 days and consist of the following:

panitumumab -9mg/kg every 21 days

Outcome Measures


Primary Outcome Measures:
1.	Overall survival: defined as the time from randomisation to the time of death due to any cause
Secondary Outcome Measures:
1.	response rate evaluated by RECIST criteria progression free survival: defined as the date of randomisation until a progression event occurs

Eligibility


Minimum Age:	18 Years
Maximum Age:
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	No
Criteria:	Inclusion Criteria: male, female 18 or over life expectancy of at least 3 months measurable disease WHO performance status 0, 1, 2 Exclusion Criteria: tumours of squamous histology previous chemotherapy (with performance status 3 and 4) major surgery within 4 weeks prior to start of study treatment (safety)

Contacts/Locations


Central Contact Person:	Prof Cunningham Telephone: 020 8661 3165 Email: david.cunningham@rmh.nhs.uk
Central Contact Backup:	Leonora Conneely Telephone: 020 8661 3807 Email: Leonora.conneely@rmh.nhs.uk
Study Officials:	Prof Cunningham, David Principal Investigator Royal Marsden NHS Foundation Trust
Locations:	United Kingdom, Surrey
	Royal Marsden NHS Foundation Trust [Recruiting] Sutton, Surrey, United Kingdom, SM2 5PT Contact:Contact: Prof Cunningham 020 8661 3165 david.cunningham@rmh.nhs.uk Contact:Contact: Leonora Conneely 020 8661 3807 leonora.conneely@rmh.nhs.uk Contact:Principal Investigator: Prof Cunningham

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