Trial Of Irinotecan In Combination With Three Methods Of Administration Of Fluoropyrimidine.
NCT ID: NCT00101686
Last Updated: 2010-01-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
547 participants
INTERVENTIONAL
2003-02-28
2008-10-31
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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Modified Bolus 5-FU/LV with Irinotecan
Modified Bolus 5-FU/LV with Irinotecan
Day 1 \& 8: Irinotecan (125 mg/m2 IV over 90 minutes), LV (20 mg/m2 IV bolus), 5-FU (500 mg/m2 IV bolus). All chemotherapy cycles repeated every 3 weeks. Celecoxib/placebo treatment will commence on the same day as chemotherapy treatment (i.e. Day 1 of treatment on study). Celecoxib/placebo will be taken at a dose of 400 mg po BID \[two times a day\] (800 mg/day) and will continue daily without interruption (no rest period for celecoxib/placebo treatment).
FOLFIRI + bevacizumab
FOLFIRI + bevacizumab
Day 1 Bevacizumab 5mg/kg IV 90 minutes prior to irinotecan/LV Irinotecan 180 mg/m2 IV 90 minutes Leucovorin 400 mg/m2 IV 2 hours - given with irinotecan without mixing.
I m m e d i a t e l y f o l l o w e d b y :
5-FU 400 mg/m2 IV bolus 5-FU 2400 mg/m2 IV Continuous infusion over 46 hours Every 2 weeks
Amendment 2 Bevacizumab 5mg/kg IV 90 minutes prior to irinotecan/LV Irinotecan 180 mg/m2 IV 90 minutes Leucovorin 400 mg/m2 IV 2 hours - given with irinotecan without mixing.
I m m e d i a t e l y f o l l o w e d b y :
5-FU 400 mg/m2 IV bolus 5-FU 2400 mg/m2 IV Continuous infusion over 46 hours Celecoxib/placebo 400 mg BID \[two times a day\] oral Every 2 weeks
miFL + bevacizumab
miFL + bevacizumab
Day 1 Bevacizumab 7.5mg/kg IV \*over 90 minutes - given prior to irinotecan, 5-FU, and leucovorin Irinotecan 125 mg/m2 IV over 90 minutes Leucovorin 20 mg/m2 IV bolus 5-FU 500 mg/m2 IV bolus Day 8 Irinotecan 125 mg/m2 IV over 90 minutes Leucovorin 20 mg/m2 IV bolus 5-FU 500 mg/m2 IV bolus Every 3 weeks Amendment 2 Day 1 Bevacizumab 7.5mg/kg IV over 90 minutes - given prior to irinotecan, 5-FU, and leucovorin Irinotecan 125 mg/m2 IV over 90 minutes Leucovorin 20 mg/m2 IV bolus 5-FU 500 mg/m2 IV bolus Celecoxib/placebo 400 mg BID \[two times a day\] oral Day 8 Irinotecan 125 mg/m2 IV over 90 minutes Leucovorin 20 mg/m2 IV bolus 5-FU 500 mg/m2 IV bolus Celecoxib/placebo -- 400 mg po BID \[two times a day\] continues daily without interruption Every 3 weeks
Infusional 5-FU/LV with Irinotecan
Infusional 5-FU/LV with Irinotecan
Day 1: Irinotecan (180 mg/m2) IV over 90 minutes, LV (racemic mixture 400 mg/m2) over 2 hours during irinotecan infusion but without mixing, immediately followed by 5-FU IV bolus (400 mg/m2) and 5-FU continuous infusion (2400 mg/m2) over 46 hours. FOLFIRI regimen is repeated every 2 weeks. Celecoxib/placebo treatment will commence on the same day at a dose of 400 mg po BID \[two times a day\](800 mg/day) and will continue daily without interruption (no rest period for celecoxib/placebo treatment).
Oral Capecitabine with Irinotecan
Oral Capecitabine with Irinotecan
Day 1: Irinotecan (250 mg/m2 IV) over 90 minutes; Day 1-14: capecitabine 1000 mg/m2 PO BID \[two times a day\] (28 single doses). All chemotherapy cycles repeated every 3 weeks. Celecoxib/placebo treatment will commence on the same day as chemotherapy treatment (i.e. Day 1 of treatment on study). Celecoxib/placebo will be taken at a dose of 400 mg po BID (800 mg/day) and will continue daily without interruption (no rest period for celecoxib/placebo treatment).
Interventions
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Modified Bolus 5-FU/LV with Irinotecan
Day 1 \& 8: Irinotecan (125 mg/m2 IV over 90 minutes), LV (20 mg/m2 IV bolus), 5-FU (500 mg/m2 IV bolus). All chemotherapy cycles repeated every 3 weeks. Celecoxib/placebo treatment will commence on the same day as chemotherapy treatment (i.e. Day 1 of treatment on study). Celecoxib/placebo will be taken at a dose of 400 mg po BID \[two times a day\] (800 mg/day) and will continue daily without interruption (no rest period for celecoxib/placebo treatment).
FOLFIRI + bevacizumab
Day 1 Bevacizumab 5mg/kg IV 90 minutes prior to irinotecan/LV Irinotecan 180 mg/m2 IV 90 minutes Leucovorin 400 mg/m2 IV 2 hours - given with irinotecan without mixing.
I m m e d i a t e l y f o l l o w e d b y :
5-FU 400 mg/m2 IV bolus 5-FU 2400 mg/m2 IV Continuous infusion over 46 hours Every 2 weeks
Amendment 2 Bevacizumab 5mg/kg IV 90 minutes prior to irinotecan/LV Irinotecan 180 mg/m2 IV 90 minutes Leucovorin 400 mg/m2 IV 2 hours - given with irinotecan without mixing.
I m m e d i a t e l y f o l l o w e d b y :
5-FU 400 mg/m2 IV bolus 5-FU 2400 mg/m2 IV Continuous infusion over 46 hours Celecoxib/placebo 400 mg BID \[two times a day\] oral Every 2 weeks
miFL + bevacizumab
Day 1 Bevacizumab 7.5mg/kg IV \*over 90 minutes - given prior to irinotecan, 5-FU, and leucovorin Irinotecan 125 mg/m2 IV over 90 minutes Leucovorin 20 mg/m2 IV bolus 5-FU 500 mg/m2 IV bolus Day 8 Irinotecan 125 mg/m2 IV over 90 minutes Leucovorin 20 mg/m2 IV bolus 5-FU 500 mg/m2 IV bolus Every 3 weeks Amendment 2 Day 1 Bevacizumab 7.5mg/kg IV over 90 minutes - given prior to irinotecan, 5-FU, and leucovorin Irinotecan 125 mg/m2 IV over 90 minutes Leucovorin 20 mg/m2 IV bolus 5-FU 500 mg/m2 IV bolus Celecoxib/placebo 400 mg BID \[two times a day\] oral Day 8 Irinotecan 125 mg/m2 IV over 90 minutes Leucovorin 20 mg/m2 IV bolus 5-FU 500 mg/m2 IV bolus Celecoxib/placebo -- 400 mg po BID \[two times a day\] continues daily without interruption Every 3 weeks
Infusional 5-FU/LV with Irinotecan
Day 1: Irinotecan (180 mg/m2) IV over 90 minutes, LV (racemic mixture 400 mg/m2) over 2 hours during irinotecan infusion but without mixing, immediately followed by 5-FU IV bolus (400 mg/m2) and 5-FU continuous infusion (2400 mg/m2) over 46 hours. FOLFIRI regimen is repeated every 2 weeks. Celecoxib/placebo treatment will commence on the same day at a dose of 400 mg po BID \[two times a day\](800 mg/day) and will continue daily without interruption (no rest period for celecoxib/placebo treatment).
Oral Capecitabine with Irinotecan
Day 1: Irinotecan (250 mg/m2 IV) over 90 minutes; Day 1-14: capecitabine 1000 mg/m2 PO BID \[two times a day\] (28 single doses). All chemotherapy cycles repeated every 3 weeks. Celecoxib/placebo treatment will commence on the same day as chemotherapy treatment (i.e. Day 1 of treatment on study). Celecoxib/placebo will be taken at a dose of 400 mg po BID (800 mg/day) and will continue daily without interruption (no rest period for celecoxib/placebo treatment).
Eligibility Criteria
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Inclusion Criteria
* Present or past histological documentation of adenocarcinoma of the colon or rectum. The site of the primary lesion must be or have been confirmed endoscopically, radiologically, or surgically to be or have been in the large bowel. Patients with a history of colorectal cancer treated by surgical resection who develop radiological or clinical evidence of metastatic cancer do not require separate histological or cytological confirmation of metastatic disease unless:
* An interval of greater than five years has elapsed between the primary surgery and the development of metastatic disease.
* The primary cancer was a Duke's A or B1.
* Physicians should consider biopsy of lesions to establish the diagnosis of metastatic colorectal cancer in each case if there is substantial clinical ambiguity regarding the nature of source of apparent metastases.
Exclusion Criteria
* Patients cannot have concurrent malignancies at study entry.
* Exceptions: Patients with prior non-colorectal malignancies will be eligible if they have been disease-free for ³ 3 years or are deemed at low risk for recurrence by their treating physician (e.g., early stage prostate cancer, melanoma or bladder cancer). Patients with squamous or basal cell carcinoma of the skin or in situ cervical cancer that have been effectively treated are eligible, even if these were diagnosed within 3 years before randomization.
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Pfizer Inc
Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Pfizer Investigational Site
Birmgingham, Alabama, United States
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Birmingham, Alabama, United States
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Birmngham, Alabama, United States
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Mobile, Alabama, United States
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Flagstaff, Arizona, United States
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Sedona, Arizona, United States
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Tucson, Arizona, United States
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Hot Spring, Arkansas, United States
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Springdale, Arkansas, United States
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Arroyo Grande, California, United States
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Fountian Valley, California, United States
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Fresno, California, United States
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Los Gatos, California, United States
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Mission Hills, California, United States
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Modesto, California, United States
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Orange, California, United States
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Oxnard, California, United States
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San Diego, California, United States
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San Jose, California, United States
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Boulder, Colorado, United States
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Norwalk, Connecticut, United States
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Stamford, Connecticut, United States
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Washington D.C., District of Columbia, United States
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Altamonte Springs, Florida, United States
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Hollywood, Florida, United States
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Lauderhill, Florida, United States
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Miami, Florida, United States
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Miami Beach, Florida, United States
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New Port Richey, Florida, United States
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Ocala, Florida, United States
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Sarasota, Florida, United States
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Tamarac, Florida, United States
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Macon, Georgia, United States
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Niles, Illinois, United States
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Rockford, Illinois, United States
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Skokie, Illinois, United States
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Fishers, Indiana, United States
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Fort Wayne, Indiana, United States
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Terre Haute, Indiana, United States
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Overland Park, Kansas, United States
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Alexandria, Louisiana, United States
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Shrevport, Louisiana, United States
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Bangor, Maine, United States
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Annapolis, Maryland, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Boston, Massachusetts, United States
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Burlington, Massachusetts, United States
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Pittsfield, Massachusetts, United States
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Grand Rapids, Michigan, United States
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Burnsville, Minnesota, United States
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Robbinsdale, Minnesota, United States
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Columbia, Missouri, United States
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Columbia, Missouri, United States
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Joplin, Missouri, United States
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St Louis, Missouri, United States
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St Louis, Missouri, United States
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Billings, Montana, United States
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Omaha, Nebraska, United States
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Las Vegas, Nevada, United States
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Hooksett, New Hampshire, United States
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Lebanon, New Hampshire, United States
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Nashua, New Hampshire, United States
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Summit, New Jersey, United States
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Albuquerque, New Mexico, United States
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Farmington, New Mexico, United States
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Santa Fe, New Mexico, United States
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Albany, New York, United States
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Manhaset, New York, United States
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Rockville Centre, New York, United States
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Asheville, North Carolina, United States
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Cary, North Carolina, United States
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Fayetteville, North Carolina, United States
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Greensboro, North Carolina, United States
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Hendersonville, North Carolina, United States
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Hickory, 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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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Bartlesville, Oklahoma, United States
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Norman, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Eugene, Oregon, United States
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Portland, Oregon, United States
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Abington, 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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Reading, Pennsylvania, United States
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Chattanooga, Tennessee, United States
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Collierville, Tennessee, United States
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Germantown, Tennessee, United States
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Jackson, Tennessee, United States
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Knoxville, Tennessee, United States
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Knoxville, Tennessee, United States
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Abilene, Texas, United States
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Arlington, Texas, United States
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Austin, Texas, United States
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Austin, Texas, United States
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Beaumont, Texas, United States
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Bedford, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Denton, Texas, United States
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El Paso, Texas, United States
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El Paso, Texas, United States
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Fort Worth, Texas, United States
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Fredericksburg, Texas, United States
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Garland, Texas, United States
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Houston, Texas, United States
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Houston, Texas, United States
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Irving, Texas, United States
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Lewisville, Texas, United States
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Longview, Texas, United States
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McAllen, Texas, United States
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Mesquite, Texas, United States
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Midland, Texas, United States
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New Braunfels, Texas, United States
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Odessa, Texas, United States
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Paris, Texas, United States
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Sherman, Texas, United States
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Temple, Texas, United States
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Tyler, Texas, United States
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Tyler, Texas, United States
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Waco, Texas, United States
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Webster, Texas, United States
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Wichita Falls, Texas, United States
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Colchester, Vermont, United States
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Fairfax, Virginia, United States
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Newport News, Virginia, United States
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Roanoke, Virginia, United States
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Edmonds, Washington, United States
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Lacy, Washington, United States
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Seattle, Washington, United States
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Spokane, Washington, United States
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Yakima, Washington, United States
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Glendale, Wisconsin, United States
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Milwaukee, Wisconsin, United States
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Waratah, New South Wales, Australia
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South Brisbane, Queensland, Australia
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Bedford Park, South Australia, Australia
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Woodville, South Australia, Australia
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Clayton, Victoria, Australia
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Frankston, Victoria, Australia
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Moncton, New Brunswick, Canada
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St. John's, Newfoundland and Labrador, Canada
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Halifax, Nova Scotia, Canada
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Sydney, Nova Scotia, Canada
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Brampton, Ontario, Canada
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Kingston, Ontario, Canada
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Kitchener, Ontario, Canada
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Mississauga, Ontario, Canada
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Newmarket, Ontario, Canada
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Oshawa, Ontario, Canada
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Ottawa, Ontario, Canada
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Scarborough Village, Ontario, Canada
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Thunder Bay, Ontario, Canada
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Windsor, Ontario, Canada
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Chicoutimi, Quebec, Canada
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Fleurimont, Quebec, Canada
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Laval, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Rimouski, Quebec, Canada
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Regina, Saskatchewan, Canada
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Saskatoon, Saskatchewan, Canada
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Auckland, , New Zealand
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Dunedin, , New Zealand
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Riccarton, , New Zealand
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Wellington, , New Zealand
Countries
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Other Identifiers
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A5961021
Identifier Type: -
Identifier Source: secondary_id
CPTAIV-0020-411
Identifier Type: -
Identifier Source: org_study_id
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