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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00561470
Registration number
NCT00561470
Ethics application status
Date submitted
20/11/2007
Date registered
21/11/2007
Date last updated
28/09/2012
Titles & IDs
Public title
Aflibercept Versus Placebo in Combination With Irinotecan and 5-FU in the Treatment of Patients With Metastatic Colorectal Cancer After Failure of an Oxaliplatin Based Regimen
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Scientific title
A Multinational, Randomized, Double-blind Study, Comparing the Efficacy of Aflibercept Once Every 2 Weeks Versus Placebo in Patients With Metastatic Colorectal Cancer (MCRC) Treated With Irinotecan / 5-FU Combination (FOLFIRI) After Failure of an Oxaliplatin Based Regimen
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Secondary ID [1]
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EudraCT 2007-000820-42
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Secondary ID [2]
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EFC10262
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Universal Trial Number (UTN)
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Trial acronym
VELOUR
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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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0
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Neoplasm Metastasis
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0
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Condition category
Condition code
Cancer
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0
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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 - Placebo
Treatment: Drugs - Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)
Treatment: Drugs - FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
Treatment: Drugs - FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
Placebo comparator: Placebo/FOLFIRI - Participants with Metastatic Colorectal Cancer administered Placebo followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) starting on Day 1 of a 2-week cycle until a treatment discontinuation criterion was met
Experimental: Aflibercept/FOLFIRI - Participants with Metastatic Colorectal Cancer administered Aflibercept followed by FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) starting on Day 1 of a 2-week cycle until a treatment discontinuation criterion was met
Treatment: Drugs: Placebo
4 mg/kg of sterile aqueous buffered vehicle (pH 6.0) was administered intra venously (IV) over 1 hour on Day 1, every 2 weeks
Treatment: Drugs: Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)
4 mg/kg of Aflibercept was administered IV over 1 hour on Day 1, every 2 weeks.
Treatment: Drugs: FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
The FOLFIRI regimen was initiated immediately after Placebo administration on Day 1
The FOLFIRI regimen included:
* 180 mg/m² Irinotecan (Campto®, Camptosar®) IV infusion over 90 minutes and dl leucovorin 400 mg/m² (200 mg/m² for the l-isomer form) IV infusion over 2 hours, followed by:
* 5-FU 400 mg/m² IV bolus given over 2-4 minutes, followed by:
* 5-FU 2400 mg/m² continuous IV infusion over 46-hours
Treatment: Drugs: FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin)
The FOLFIRI regimen was initiated immediately after Aflibercept administration on Day 1
The FOLFIRI regimen included:
* 180 mg/m² Irinotecan (Campto®, Camptosar®) IV infusion over 90 minutes and dl leucovorin 400 mg/m² (200 mg/m² for the l-isomer form) IV infusion over 2 hours, followed by:
* 5-FU 400 mg/m² IV bolus given over 2-4 minutes, followed by:
* 5-FU 2400 mg/m² continuous IV infusion over 46-hours
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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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Overall Survival (OS)
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Assessment method [1]
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Overall Survival was the time interval from the date of randomization to the date of death due to any cause. Once disease progression was documented, participants were followed every 2 months for survival status, until death or until the study cutoff date, whichever came first. The final data cutoff date for the analysis of OS was the date when 863 deaths had occurred (07 February 2011).
OS was estimated using the Kaplan-Meier method, and the Hazard Ratio was estimated using the Cox Proportional Hazard Model.
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Timepoint [1]
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From the date of the first randomization until the study data cut-off date, 07 February 2011 (approximately three years)
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Secondary outcome [1]
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Progression-free Survival (PFS) Assessed by Independent Review Committee (IRC)
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Assessment method [1]
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PFS was the time interval from the date of randomization to the date of progression, or death from any cause if it occurs before tumor progression is documented. To evaluate disease progression, copies of all tumor imaging sets were systematically collected and assessed by the IRC.
PFS was analyzed using the Kaplan-Meier method, and the Hazard Ratio was estimated using the Cox Proportional Hazard Model.
The analysis for PFS was performed as planned when 561 deaths (OS events) had occurred.
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Timepoint [1]
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From the date of the first randomization until the occurrence of 561 OS events, 06 May 2010 (approximately 30 months)
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Secondary outcome [2]
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Overall Objective Response Rate (ORR) Based on the Tumor Assessment by the Independent Review Committee (IRC) as Per Response Evaluation Criteria in Solid Tumours (RECIST) Criteria
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Assessment method [2]
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The overall ORR was the percentage of evaluable participants who achieved complete response \[CR\] or partial response \[PR\] according to RECIST criteria version 1.0.
* CR reflected the disappearance of all tumor lesions (with no new tumors)
* PR reflected a pre-defined reduction in tumor burden
Tumors were assessed by the IRC using Computerized Tomography (CT) scans or Magnetic Resonance Imaging (MRI) scans; and an observed response was confirmed by repeated imaging after 4 - 6 weeks.
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Timepoint [2]
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From the date of the first randomization until the study data cut-off date, 06 May 2010 (approximately 30 months)
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Secondary outcome [3]
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Number of Participants With Adverse Events (AE)
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Assessment method [3]
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All AEs regardless of seriousness or relationship to study treatment, spanning from the first administration of study treatment until 30 days after the last administration of study treatment, were recorded, and followed until resolution or stabilization.
The number of participants with all treatment emergent adverse events (TEAE), serious adverse events (SAE), TEAE leading to death, and TEAE leading to permanent treatment discontinuation are reported.
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Timepoint [3]
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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 [4]
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Immunogenicity Assessment: Number of Participants With Positive Sample(s) in the Anti-drug Antibodies (ADA) Assay and in the Neutralizing Anti-drug Antibodies (NAb) Assay
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Assessment method [4]
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Serum samples for immunogenicity assessment were analyzed using a bridging immunoassay to detect ADA. Positive samples in the ADA assay were further analyzed in the NAb assay using a validated, non-quantitative ligand binding assay.
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Timepoint [4]
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Baseline, every other treatment cycle, 30 days and 90 days after the last infusion of aflibercept/placebo
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Eligibility
Key inclusion criteria
Participants who met the following main selection criteria were included in the study.
* Histologically or cytologically proven adenocarcinoma of the colon or rectum
* Metastatic disease that is not amenable to potentially curative treatment
* One and only one prior line of treatment for metastatic disease. This prior line should be an oxaliplatin based chemotherapy (participants who relapse within 6 months of completion of oxaliplatin based adjuvant chemotherapy are eligible)
* Prior treatment with bevacizumab is permitted.
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Minimum age
18
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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 with irinotecan
* Eastern Cooperative Oncology Group performance status >2
The above information is not intended to contain all considerations relevant to 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
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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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
1/11/2007
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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
1/06/2012
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Sample size
Target
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Accrual to date
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Final
1226
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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 - Hornsby
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Sanofi-Aventis Investigational Site Number 036001 - Kingswood
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Sanofi-Aventis Investigational Site Number 036002 - Kurralta Park
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Sanofi-Aventis Investigational Site Number 036005 - Melbourne
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Sanofi-Aventis Investigational Site Number 036003 - Melbourne
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Sanofi-Aventis Investigational Site Number 036007 - Nedlands
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Sanofi-Aventis Investigational Site Number 036006 - Subiaco
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2077 - Hornsby
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2747 - Kingswood
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5037 - Kurralta Park
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3050 - Melbourne
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3128 - Melbourne
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6009 - Nedlands
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6008 - Subiaco
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Recruitment outside Australia
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Reus
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Sweden
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Stockholm
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Sweden
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Sundsvall
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Sweden
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Uppsala
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Turkey
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Adana
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Turkey
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Ankara
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Turkey
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Izmir
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Turkey
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Kayseri
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Ukraine
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Dnipropetrovsk
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Ukraine
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Donetsk
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Ukraine
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Kharkiv
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Ukraine
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Kharkov
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United Kingdom
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Aberdeen
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United Kingdom
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Bournemouth
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United Kingdom
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Dudley
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United Kingdom
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London
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United Kingdom
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Manchester
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United Kingdom
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Northwood
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United Kingdom
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Sutton
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Sanofi
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Commercial sector/industry
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Regeneron Pharmaceuticals
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Other
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NSABP Foundation Inc
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Ethics approval
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Summary
Brief summary
The main objective of the study was to evaluate the effectiveness of aflibercept (versus placebo) in increasing the overall survival in participants with metastatic colorectal cancer treated with FOLFIRI (Irinotecan, 5-Fluorouracil, and Leucovorin) and that have previously failed an oxaliplatin based treatment for metastatic disease. The secondary objectives were to compare progression-free survival, to evaluate overall response rate, to evaluate the safety profile, to assess immunogenicity of intravenous (IV) aflibercept, and to assess pharmacokinetics of IV aflibercept in both treatment arms.
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Trial website
https://clinicaltrials.gov/study/NCT00561470
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Trial related presentations / publications
Lu L, Dercle L, Zhao B, Schwartz LH. Deep learning for the prediction of early on-treatment response in metastatic colorectal cancer from serial medical imaging. Nat Commun. 2021 Nov 17;12(1):6654. doi: 10.1038/s41467-021-26990-6. Chau I, Fakih M, Garcia-Alfonso P, Linke Z, Ruiz Casado A, Marques EP, Picard P, Celanovic M, Cartwright T. Safety and Effectiveness of Aflibercept + Fluorouracil, Leucovorin, and Irinotecan (FOLFIRI) for the Treatment of Patients with Metastatic Colorectal Cancer (mCRC) in Current Clinical Practice: OZONE Study. Cancers (Basel). 2020 Mar 11;12(3):657. doi: 10.3390/cancers12030657. Ruff P, Van Cutsem E, Lakomy R, Prausova J, van Hazel GA, Moiseyenko VM, Soussan-Lazard K, Dochy E, Magherini E, Macarulla T, Papamichael D. Observed benefit and safety of aflibercept in elderly patients with metastatic colorectal cancer: An age-based analysis from the randomized placebo-controlled phase III VELOUR trial. J Geriatr Oncol. 2018 Jan;9(1):32-39. doi: 10.1016/j.jgo.2017.07.010. Epub 2017 Aug 12. Stanel SC, Sjoberg J, Salmonson T, Foggi P, Caleno M, Melchiorri D, Gravanis I, Tzogani K, Pignatti F. European Medicines Agency approval summary: Zaltrap for the treatment of patients with oxaliplatin-resistant metastatic colorectal cancer. ESMO Open. 2017 May 2;2(2):e000190. doi: 10.1136/esmoopen-2017-000190. eCollection 2017. Van Cutsem E, Joulain F, Hoff PM, Mitchell E, Ruff P, Lakomy R, Prausova J, Moiseyenko VM, van Hazel G, Cunningham D, Arnold D, Schmoll HJ, Ten Tije AJ, McKendrick J, Kroning H, Humblet Y, Gravalos C, Le-Guennec S, Andria M, Dochy E, Vishwanath RL, Macarulla T, Tabernero J. Aflibercept Plus FOLFIRI vs. Placebo Plus FOLFIRI in Second-Line Metastatic Colorectal Cancer: a Post Hoc Analysis of Survival from the Phase III VELOUR Study Subsequent to Exclusion of Patients who had Recurrence During or Within 6 Months of Completing Adjuvant Oxaliplatin-Based Therapy. Target Oncol. 2016 Jun;11(3):383-400. doi: 10.1007/s11523-015-0402-9. Tabernero J, Van Cutsem E, Lakomy R, Prausova J, Ruff P, van Hazel GA, Moiseyenko VM, Ferry DR, McKendrick JJ, Soussan-Lazard K, Chevalier S, Allegra CJ. Aflibercept versus placebo in combination with fluorouracil, leucovorin and irinotecan in the treatment of previously treated metastatic colorectal cancer: prespecified subgroup analyses from the VELOUR trial. Eur J Cancer. 2014 Jan;50(2):320-31. doi: 10.1016/j.ejca.2013.09.013. Epub 2013 Oct 16. Van Cutsem E, Tabernero J, Lakomy R, Prenen H, Prausova J, Macarulla T, Ruff P, van Hazel GA, Moiseyenko V, Ferry D, McKendrick J, Polikoff J, Tellier A, Castan R, Allegra C. Addition of aflibercept to fluorouracil, leucovorin, and irinotecan improves survival in a phase III randomized trial in patients with metastatic colorectal cancer previously treated with an oxaliplatin-based regimen. J Clin Oncol. 2012 Oct 1;30(28):3499-506. doi: 10.1200/JCO.2012.42.8201. Epub 2012 Sep 4.
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Public notes
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Contacts
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Clinical Sciences & Operations
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Sanofi
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00561470
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