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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00439517
Registration number
NCT00439517
Ethics application status
Date submitted
22/02/2007
Date registered
23/02/2007
Date last updated
27/06/2014
Titles & IDs
Public title
Study to Evaluate the Efficacy and Safety of FOLFOX-4 Plus Cetuximab Versus UFOX Plus Cetuximab.
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Scientific title
A Randomized, Open-label Phase II Study Evaluating the Efficacy and Safety of FOLFOX-4 Plus Cetuximab Versus UFOX Plus Cetuximab as First-line Therapy in Subjects With Metastatic Colorectal Cancer.
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Secondary ID [1]
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EMR200025-001
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Universal Trial Number (UTN)
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Trial acronym
FUTURE
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Previously Untreated Metastatic Colorectal Cancer
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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 - UFOX + Cetuximab
Treatment: Drugs - FOLFOX4 + Cetuximab
Experimental: 1 - UFOX + Cetuximab
Active comparator: 2 - FOLFOX4 + Cetuximab
Treatment: Drugs: UFOX + Cetuximab
* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22)
* Oxaliplatin infusion (85mg/m\^2) on days 1 and 15 (every 2 weeks)
* Oral UFT® (250mg/m\^2 tegafur + 560 mg/m\^2 uracil in 3 daily doses rounded to the nearest number of whole capsules) on days 1-21
* Oral Folinic Acid (90 mg in 3 daily divided doses) on days 1-21
Treatment: Drugs: FOLFOX4 + Cetuximab
* Cetuximab infusion (400 mg/m\^2 on day 1 of cycle 1 and 250 mg/m\^2 at each subsequent day 1, as well as on days 8, 15 and 22)
* Oxaliplatin infusion (85 mg/m\^2) on days 1 and 15 (every 2 weeks)
* 5-FU bolus + infusions (400 mg/m\^2) on days 1, 2, 15 and 16
* Folinic Acid infusions (200 mg/m\^2) on days 1, 2, 15 and 16
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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)
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Assessment method [1]
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Duration from randomization until progression or death due to any cause. Only deaths within 12 weeks of last tumor assessment are considered. Patients without event are censored on the date of last tumor assessment. Response and progression were assessed by the Investigators using response evaluation criteria in solid tumors (RECIST) 1.0 criteria
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Timepoint [1]
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Time from randomization to disease progression, death, or last tumor assessment reported between day of first patient randomised, Feb 2007, until cut off date, 30 Jun 2009
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Secondary outcome [1]
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Best Overall Response (BOR)
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Assessment method [1]
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BOR defined as percentage of subjects, whose BOR was either (confirmed) complete response (CR) or partial response (PR), relative to the number of subjects belonging to the study population of interest. CR defined as "Disappearance of all target lesions plus disappearance of all non-target lesions \& without appearance of any new lesions; confirmed minimum 4 weeks later. PR defined as "At least 30% reduction in the SOLD of target lesions plus no significant change in non-target lesions to qualify for either CR or PD without appearance of new lesions; confirmed minimum 4 weeks later
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Timepoint [1]
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Evaluations were performed every 8 weeks until disease progression, reported between day of first patient randomised, Feb 2007, until cut off date, 30 Jun 2009
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Secondary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.
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Timepoint [2]
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Time from randomization to death or last known to be alive, reported between day of first patient randomised, Feb 2007, until cut off date, 30 Jun 2009
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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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Time from randomization to death. Patients without event are censored at the last date known to be alive or at the clinical cut-off date, whatever is earlier.
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Timepoint [3]
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Time from randomization to death or last known to be alive, reported between day of first patient randomised, Feb 2007, until cut off date, 31 Aug 2011
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Secondary outcome [4]
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Quality of Life (QOL) Functional Assessment of Cancer Therapy-Colorectal (FACT-C)
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Assessment method [4]
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All of the single-item measures of the FACT-C are assessed on ordinal response categories ranging from 0="Not at all" to 4="Very much". For scoring purposes the response scores are reversed on negatively phrased questions. The principle for scoring the sub-scales is the same in all cases: subscale score = (Sum of items × Number of items in the subscale) / numbers of items answered. The lowest possible total score is 0 and the highest is 136. A high scale score represents a high QOL.
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Timepoint [4]
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At baseline, at every first day of every third cycle during active - treatment, and at final tumor assessment , reported between day of first patient randomised, Feb 2007, until cut-off date, 30 Jun 2009. Cycles were 4 weeks long unless dosing delays
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Secondary outcome [5]
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QOL EuroQuol-5D (EQ-5D) Health Outcome Questionnaire
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Assessment method [5]
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The EQ-5D questionnaire is a measure of health status that provides a simple descriptive profile and a single index value. The optional part of the questionnaire was not applied. The EQ-5D defines health in terms of mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The 5 items are combined to generate health profiles. These profiles were converted to a continuous single index score using a one to one matching. The lowest possible score is -0.59 and the highest is 1.00, higher scores on the EQ-5D represent a better QOL.
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Timepoint [5]
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at baseline, at every first day of every third cycle during active - treatment, and at final tumor assessment , reported between day of first patient randomised, Feb 2007, until cut-off date, 30 Jun 2009. All cycles were 4 weeks long unless dosing delays
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Secondary outcome [6]
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QOL Therapy Preference Questionnaire (TPQ)
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Assessment method [6]
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TPQ was used to investigate which features of chemotherapy treatment are the most relevant in ensuring patient satisfaction. The most essential characteristics of a cancer medication are shown at baseline and at cycle 3, along with percentage of subjects selecting that characteristic.
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Timepoint [6]
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at baseline, at every first day of every third cycle during active - treatment, and at final tumor assessment , reported between day of first patient randomised, Feb 2007, until cut-off date, 30 Jun 2009. All cycles were 4 weeks long unless dosing delays
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Secondary outcome [7]
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Treatment Impact on Social Daily Living and Health Care Resource Utilization
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Assessment method [7]
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Non-protocol medical care visits and consultations
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Timepoint [7]
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From randomisation until final visit, reported between day of first patient randomised, Feb 2007, until cut-off date, 30 Jun 2009
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Secondary outcome [8]
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Safety - Number of Patients Experiencing Any Adverse Event
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Assessment method [8]
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Please refer to Adverse Events section for details of individual serious adverse events and other adverse events
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Timepoint [8]
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Time from first dose up to 30 days after last dose of study treatment, reported between day of first patient randomised, Feb 2007, until cut off date, 30 Jun 2009
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Eligibility
Key inclusion criteria
Inclusion Criteria
* Signed written informed consent
* Inpatient or outpatient = 18 years of age
* Diagnosis of histologically confirmed adenocarcinoma of the colon or rectum
* First occurrence of metastatic disease (not curatively resectable)
* Presence of at least one lesion measurable uni dimensionally by computerised tomography (CT) scan or magnetic resonance imaging (MRI). (Target lesion(s) must not lie within an irradiated area)
* Life expectancy of = 3 months
* Karnofsky performance status of = 60, at study entry
* White blood cell count (WBC) = 3 x 10^9/L, with neutrophils = 1.5 x 10^9/L, platelets = 100 x 10^9/L, and hemoglobin = 9 g/dL
* Aspartate transaminase and alanine transaminase = 2.5 x Upper Limit of Normal (ULN) (= 5 x ULN if liver metastasis are present)
* Normal serum creatinine (in case of elevated creatinine, labelled ethylenediaminetetraacetic acid clearance = 65 mL/min is acceptable)
* Effective contraception for both male and female subjects if the risk of conception exists
* Tumor biopsy or archived sample available
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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
Exclusion criteria:
* Brain metastasis and/or leptomeningeal disease (known or suspected)
* Previous chemotherapy for colorectal cancer except adjuvant treatment with progression of disease documented > 6 months after end of adjuvant treatment.
* Previous oxaliplatin-based chemotherapy
* Surgery (excluding diagnostic biopsy) or irradiation within 4 weeks prior to randomization
* Concurrent or previous chronic systemic immune therapy, targeted therapy, anti-vascular epithelial growth factor (VEGF) therapy, epidermal growth factor receptor (EGFR) pathway targeting therapy not indicated in the study protocol
* Concurrent hormonal therapy not indicated in the study protocol except for physiologic replacement or contraception
* Clinically relevant coronary artery disease, history of myocardial infarction in the last 12 months, or high risk of uncontrolled arrhythmia
* Peripheral neuropathy >grade 1
* Known hypersensitivity reaction to any of the components of the treatment.
* Any concurrent malignancy other than basal cell cancer of the skin, or pre-invasive cancer of the cervix. (Subjects with a previous malignancy but without evidence of disease for = 5 years will be allowed to enter the study)
* Pregnancy (absence to be confirmed by ß-human chorionic gonadotrophin test) or lactation period
* Known drug abuse/alcohol abuse
* Legal incapacity or limited legal capacity
* Medical or psychological condition which in the opinion of the investigator would not permit the subject to complete the study or sign meaningful informed consent
* Participation in another clinical study within the 30 days before randomization
* Significant disease which, in the investigator's opinion, would exclude the subject from the study
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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
1/02/2007
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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
1/05/2012
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Sample size
Target
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Accrual to date
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Final
302
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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Research Site - Perth
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Recruitment hospital [2]
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Research Site - Wollongong
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Recruitment postcode(s) [1]
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- Perth
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Recruitment postcode(s) [2]
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- Wollongong
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Recruitment outside Australia
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autónoma Buenos Aires
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Austria
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Graz
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Austria
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Wien
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Belgium
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Leuven
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Belgium
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Liège
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Brazil
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Belo Horizonte
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Brazil
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Cep Sao Paulo-SP
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Brazil
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Fortaleza
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Besancon Cedex
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France
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France
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La Roche sur Yon
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France
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Lille
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France
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Marseille
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France
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Nice
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France
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Saint-Herblain
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France
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Germany
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Berlin
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Dortmund
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Germany
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Germany
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Heidelberg
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Germany
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Kassel
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Germany
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Krefeld
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Germany
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Germany
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Oldenburg
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Germany
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Wiesbaden
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Greece
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Dragana
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Thessaloniki
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Voutes
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Hong Kong
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Hong Kong
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Sha Tin
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Israel
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Haifa
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Israel
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Forli
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Padova
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Pavia
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Potenza
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Italy
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Reggio Emilia
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Italy
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Rimini
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Italy
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Roma
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Italy
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Sassari
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Mexico
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Mexico-City
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Poland
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Krakow
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Poland
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Lublin
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Opole
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Warsaw
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Thailand
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Bangkok
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Thailand
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Pathumwan
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Merck KGaA, Darmstadt, Germany
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
This is an exploratory study to compare activity and safety in 400 patients with previously untreated metastatic carcinoma of the colon treated with UFOX (a combination regimen of UFT® (Tegafur plus Uracil), Oxaliplatin, Folinic Acid) plus Cetuximab or FOLFOX-4 (a combination regimen of 5 Fluorouracil (5-FU), Oxaliplatin and Folinic Acid) plus Cetuximab)
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Trial website
https://clinicaltrials.gov/study/NCT00439517
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Trial related presentations / publications
Douillard JY, Zemelka T, Fountzilas G, Barone C, Schlichting M, Heighway J, Eggleton SP, Srimuninnimit V. FOLFOX4 with cetuximab vs. UFOX with cetuximab as first-line therapy in metastatic colorectal cancer: The randomized phase II FUTURE study. Clin Colorectal Cancer. 2014 Mar;13(1):14-26.e1. doi: 10.1016/j.clcc.2013.11.009. Epub 2013 Nov 16.
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Public notes
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Contacts
Principal investigator
Name
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Jean-Yves Douillard, MD PhD
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Address
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Centre R Gauducheau
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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
Type
Citations or Other Details
Journal
Douillard JY, Zemelka T, Fountzilas G, Barone C, S...
[
More Details
]
Results are available at
https://clinicaltrials.gov/study/NCT00439517
Download to PDF