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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00851084
Registration number
NCT00851084
Ethics application status
Date submitted
24/02/2009
Date registered
25/02/2009
Date last updated
7/06/2016
Titles & IDs
Public title
Study of Aflibercept And Modified FOLFOX6 As First-Line Treatment In Patients With Metastatic Colorectal Cancer
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Scientific title
Randomized, Multinational, Study Of Aflibercept And Modified FOLFOX6 As First-Line Treatment In Patients With Metastatic Colorectal Cancer
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Secondary ID [1]
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EudraCT 2008-004178-41
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Secondary ID [2]
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EFC10668
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Universal Trial Number (UTN)
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Trial acronym
AFFIRM
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Colorectal Neoplasms
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Neoplasm Metastasis
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Condition category
Condition code
Cancer
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - aflibercept
Treatment: Drugs - oxaliplatin
Treatment: Drugs - 5-FU
Treatment: Drugs - Folinic Acid
Active Comparator: mFOLFOX6 only - modified FOLFOX6 chemotherapy regimen
Experimental: mFOLFOX6 + aflibercept - modified FOLFOX6 chemotherapy regimen in combination with aflibercept
Treatment: Drugs: aflibercept
administration: IV infusion
Treatment: Drugs: oxaliplatin
administration: IV infusion
Treatment: Drugs: 5-FU
administration: IV infusion
Treatment: Drugs: Folinic Acid
administration: IV infusion
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression Free Survival (PFS) Rate at 12 Months
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Assessment method [1]
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PFS rate at 12 months was defined as the percentage of patients alive without disease progression at 12 months after randomization. The primary efficacy analysis was based on assessment by the Independent Review Committee (IRC). The study was not powered for comparison of PFS rate at 12 months between the two arms (non-comparative, open-label study). Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.0), as at least a 20 percent increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions.
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Timepoint [1]
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12 months
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Secondary outcome [1]
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Progression Free Survival (PFS)
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Assessment method [1]
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PFS was defined as the time from the date of randomization to the date of tumor progression or death from any cause, whichever occurred first. PFS was based on tumor assessment by the Independent Review Committee (IRC). PFS was estimated from Kaplan-Meier Curves.
The study was not powered for comparison of PFS between the two arms (non-comparative, open-label study).
Progression was defined using Response Evaluation Criteria In Solid Tumors (RECIST v1.0), as at least a 20 percent increase in the sum of the longest diameter (LD) of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions and/or unequivocal progression of existing non target-lesions.
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Timepoint [1]
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From the date of the first randomization until the study data cut-off date, 14 April 2011 (approximately 26 months)
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Secondary outcome [2]
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Overall Objective Response Rate (ORR)
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Assessment method [2]
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Summary of overall objective response rate based on tumor assessment by the Independent Review Committee (IRC) as per Response Evaluation Criteria in Solid Tumours (RECIST) criteria. ORR was defined as the proportion of patients with confirmed Complete Response (CR) or confirmed Partial Response (PR) relative to the total number of patients in the analysis population.
Per RECIST v 1.0 target lesions evaluation and assessed by tumor imaging: Complete Response (CR): Disappearance of all target lesions; Partial Response (PR): >=30% decrease in the sum of the longest diameter (LD) of target lesions, taking as reference the baseline sum LD.
The study was not powered for comparison of ORR between the two arms (non-comparative, open-label study).
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Timepoint [2]
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From the date of the first randomization until the study data cut-off date, 14 April 2011 (approximately 26 months)
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Secondary outcome [3]
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Overall Survival (OS)
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Assessment method [3]
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Overall survival was defined as the time from the date of randomization to the date of death due to any cause. In absence of confirmation of death, survival time was censored at the earliest between the last date the patient was known to be alive and the study cutoff date.
The study was not powered for comparison of OS between the two arms (non-comparative, open-label study).
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Timepoint [3]
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From the date of the first randomization until the study data cut-off date, 14 April 2011 (approximately 26 months)
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Secondary outcome [4]
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Number of Participants With Treatment-emergent Adverse Events (TEAE)
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Assessment method [4]
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Summary of treatment-emergent adverse events in the safety population. The National Cancer Institute Common Terminology Criteria for Adverse Event (NCI-CTCAE), version 3.0 was used in this study to grade the severity of AEs.
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Timepoint [4]
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From the date of the first randomization up to 30 days after the treatment discontinuation or until TEAE was resolved or stabilized
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Secondary outcome [5]
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Immunogenicity of Intravenous (IV) Aflibercept
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Assessment method [5]
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The antidrug antibody (ADA) assay was evaluated for participants receiving aflibercept.
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Timepoint [5]
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Any time post baseline and 90 days after the last infusion of aflibercept, according to baseline status
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Eligibility
Key inclusion criteria
- Histologically proven adenocarcinoma of the colon or the rectum
- Metastatic disease not amenable to potentially curative treatment
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Prior therapy for metastatic cancer of the colon or the rectum
- Prior treatment with angiogenesis inhibitors
The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/02/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/01/2012
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Sample size
Target
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Accrual to date
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Final
268
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Sanofi-Aventis Investigational Site Number 036004 - Douglas
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Recruitment hospital [2]
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Sanofi-Aventis Investigational Site Number 036001 - Hunter Region Mail Centre
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Recruitment hospital [3]
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Sanofi-Aventis Investigational Site Number 036003 - Hunter Region Mail Centre
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Recruitment postcode(s) [1]
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4814 - Douglas
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Recruitment postcode(s) [2]
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2310 - Hunter Region Mail Centre
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Recruitment outside Australia
Country [1]
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Germany
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State/province [1]
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Berlin
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Country [2]
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Germany
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State/province [2]
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Dresden
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Germany
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State/province [3]
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Hannover
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Germany
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Homberg
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Germany
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State/province [5]
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Mannheim
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Germany
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State/province [6]
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Münster
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Germany
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State/province [7]
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Recklinghausen
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Italy
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State/province [8]
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Bari
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Italy
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Firenze
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Italy
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Milano
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Italy
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Taormina
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Italy
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Torino
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Korea, Republic of
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State/province [13]
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Busan
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Korea, Republic of
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State/province [14]
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Cheongju
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Korea, Republic of
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State/province [15]
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Daegu
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Korea, Republic of
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State/province [16]
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Daejeon
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Korea, Republic of
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State/province [17]
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Goyang-Si, Gyeonggi-Do
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Korea, Republic of
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Seoul
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Korea, Republic of
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Ulsan
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Russian Federation
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Pyatigorsk
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Russian Federation
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State/province [21]
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Saint-Petersburg
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Russian Federation
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Sochi
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Spain
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Barcelona
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Spain
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Madrid
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Spain
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Sabadell
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Spain
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State/province [26]
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Santiago De Compostela
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Spain
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Valencia
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United Kingdom
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Leeds
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United Kingdom
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Leicester
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United Kingdom
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Manchester
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United Kingdom
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Slough
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Country [32]
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United Kingdom
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State/province [32]
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Southampton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Sanofi
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The primary objective of the study is to estimate the progression-free survival rate at 12
months for the two arms of the study.
Secondary objectives include the evaluation of overall objective response rate to treatment,
progression-free survival, overall survival, safety and documentation of potential
immunogenicity of aflibercept.
This study was a non-comparative randomized trial and was not powered for a comparison of any
of the efficacy endpoints.
Rather, the aim of the trial was to get, for all endpoints, an estimation of the efficacy and
safety of aflibercept combined with a modified FOLFOX6 regimen. In such type of
non-comparative randomized trial, the control FOLFOLX6 arm was intended to only act as a
check on the similarity of the current patients to the historical controls with respect to
clinical outcome when given FOLFOX6 treatment.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00851084
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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John Zalcberg, MD
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Address
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Peter Mc Callum Cancer Centre, Melbourne, Australia
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00851084
Download to PDF