Study of Irinotecan and Cetuximab Versus Irinotecan as Second-Line Treatment in Patients With Metastatic, EGFR-Positive Colorectal Cancer
NCT ID: NCT00063141
Last Updated: 2010-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1302 participants
INTERVENTIONAL
2003-04-30
2007-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A
cetuximab
Vial, IV, 400 mg/m² week 1 then 250 mg/m², weekly, until PD/Toxicity/Pt-PI Decision
Irinotecan
Vial, IV, 350 mg/m², Q 3 Weeks, Until PD/Toxicity/Pt-PI Decision
Arm B
Irinotecan
Vial, IV, 350 mg/m², Q 3 Weeks, Until PD/Toxicity/Pt-PI Decision
Interventions
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cetuximab
Vial, IV, 400 mg/m² week 1 then 250 mg/m², weekly, until PD/Toxicity/Pt-PI Decision
Irinotecan
Vial, IV, 350 mg/m², Q 3 Weeks, Until PD/Toxicity/Pt-PI Decision
Irinotecan
Vial, IV, 350 mg/m², Q 3 Weeks, Until PD/Toxicity/Pt-PI Decision
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Prior oxaliplatin administered for the first-line treatment of metastatic colorectal cancer.
* Prior fluoropyrimidine-containing regimen (5-fluorouracil \[5-FU\], capecitabine, or uracil/tegafur \[UFT\]), for the first-line treatment of metastatic disease.
Exclusion Criteria
* Unresolved diarrhea, bowel obstruction, or history of inflammatory bowel disease
* Known or documented brain metastases
18 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Eli Lilly and Company
INDUSTRY
Responsible Party
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ImClone Systems
Principal Investigators
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E-mail: ClinicalTrials@ ImClone.com
Role: STUDY_CHAIR
Eli Lilly and Company
Locations
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ImClone Investigational Site
Tucson, Arizona, United States
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Pine Bluff, Arkansas, United States
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Bakersfield, California, United States
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Berkeley, California, United States
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Beverly Hills, California, United States
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Corona, California, United States
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Gilroy, California, United States
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Greenbrae, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Montebello, California, United States
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Orange, California, United States
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Palm Springs, California, United States
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Rancho Mirage, California, United States
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San Diego, California, United States
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Stockton, California, United States
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Vallejo, California, United States
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Aurora, Colorado, United States
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Denver, Colorado, United States
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New Haven, Connecticut, United States
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New London, Connecticut, United States
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Norwich, Connecticut, United States
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Stamford, Connecticut, United States
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Fort Myers, Florida, United States
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Fort Myers, Florida, United States
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Inverness, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Lakeland, Florida, United States
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Miami, Florida, United States
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New Port Richey, Florida, United States
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Orlando, Florida, United States
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Port Saint Lucie, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Columbus, Georgia, United States
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Macon, Georgia, United States
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Savannah, Georgia, United States
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Tucker, Georgia, United States
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Honolulu, Hawaii, United States
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Naperville, Illinois, United States
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South Bend, Indiana, United States
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Kansas City, Kansas, United States
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Overland Park, Kansas, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Richmond, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Lafayette, Louisiana, United States
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Metairie, Louisiana, United States
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Shreveport, Louisiana, United States
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Baltimore, Maryland, United States
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Frederick, Maryland, United States
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Boston, Massachusetts, United States
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Ann Arbor, Michigan, United States
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Detroit, Michigan, United States
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Southfield, Michigan, United States
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Minneapolis, Minnesota, United States
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Robbinsdale, Minnesota, United States
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Saint Louis Park, Minnesota, United States
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Jackson, Mississippi, United States
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Kansas City, Missouri, United States
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Rolla, Missouri, United States
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St Louis, Missouri, United States
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Trenton, New Jersey, United States
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Voorhees Township, New Jersey, United States
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Albany, New York, United States
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East Setauket, New York, United States
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Latham, New York, United States
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Mineola, New York, United States
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New York, New York, United States
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Rexford, New York, United States
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Stony Brook, New York, United States
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The Bronx, New York, United States
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Valhalla, New York, United States
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Durham, North Carolina, United States
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Greenville, North Carolina, United States
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High Point, North Carolina, United States
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Raleigh, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Bismarck, North Dakota, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Newark, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Hershey, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Greenville, South Carolina, United States
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Knoxville, Tennessee, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Plano, Texas, United States
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Temple, Texas, United States
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Ogden, Utah, United States
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Arlington, Virginia, United States
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Danville, Virginia, United States
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Newport News, Virginia, United States
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Richmond, Virginia, United States
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Seattle, Washington, United States
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Spokane, Washington, United States
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Spokane, Washington, United States
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Walla Walla, Washington, United States
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Green Bay, Wisconsin, United States
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Madison, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Perth, Australian Capital Territory, Australia
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Sydney, Australian Capital Territory, Australia
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Sydney, New South Wales, Australia
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Wollongong, New South Wales, Australia
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South Brisbane, Queensland, Australia
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Adelaide, South Australia, Australia
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Wien, , Australia
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Graz, , Austria
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Salzburg, , Austria
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Vienna, , Austria
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Wein, , Austria
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Charleroi, , Belgium
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Brno, , Czechia
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Olomouc, , Czechia
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Prague, , Czechia
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Helsinki, , Finland
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Avignon, , France
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Marseille, , France
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Nice, , France
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Saint-Herblain, , France
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Aschaffenburg, , Germany
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Augsburg, , Germany
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Dessau, , Germany
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Dortmund, , Germany
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Essen, , Germany
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Hamburg, , Germany
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Hanburg, , Germany
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Kaiserslautern, , Germany
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Kassel, , Germany
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Magdeburg, , Germany
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Mainz, , Germany
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Mannheim, , Germany
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Muchnhen, , Germany
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München, , Germany
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Regensburg, , Germany
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Saarbrücken, , Germany
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Stralsund, , Germany
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Stuttgart, , Germany
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Hong Kong, , Hong Kong
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Rozzano, Milano, Italy
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Ancona, , Italy
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Bergamo, , Italy
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Candiolo, , Italy
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Florence, , Italy
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Genova, , Italy
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Livomo, , Italy
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Milan, , Italy
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Modena, , Italy
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Napoli, , Italy
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Perugia, , Italy
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Reggio Emilia, , Italy
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Roma, , Italy
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Rome, , Italy
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Apeldoorn, , Netherlands
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Dordrecht, , Netherlands
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Montebello, Oslo County, Norway
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Oslo, , Norway
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Porto, , Portugal
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Bratislava, , Slovakia
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Lund, , Sweden
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Stockholm, , Sweden
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Bern, , Switzerland
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Liestal, , Switzerland
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Zurich, , Switzerland
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Foresterhill, Aberdeenshire, United Kingdom
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Hull, Avon, United Kingdom
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Glasgow, Central, United Kingdom
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Poole, Dorset, United Kingdom
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London, Greater London, United Kingdom
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Bournemouth, Hampshire, United Kingdom
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Guildford, Surrey, United Kingdom
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Sutton, Surrey, United Kingdom
Countries
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Other Identifiers
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CA225-006
Identifier Type: -
Identifier Source: org_study_id
NCT00065598
Identifier Type: -
Identifier Source: nct_alias
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