Spots Global Cancer Trial Database for A Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer
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Trial Identification
Brief Title: A Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer
Official Title: An Open-Label Randomized Phase III Study of Intermittent Oral Capecitabine in Combination With Intravenous Oxaliplatin (Q3W) ("XELOX") Versus Bolus and Continuous Infusion Fluorouracil/ Intravenous Leucovorin With Intravenous Oxaliplatin (Q2W) ("FOLFOX4") as Treatment for Patients With Metastatic Colorectal Cancer Who Have Received Prior Treatment With CPT-11 in Combination With 5-FU/LV as First Line Therapy
Study ID: NCT00069108
Conditions
Study Description
Brief Summary: This 2 arm study will assess the efficacy and safety of intermittent oral Xeloda, or iv fluorouracil/leucovorin, in combination with intravenous Eloxatin (oxaliplatin) in patients previously treated for metastatic colorectal cancer. Patients will be randomized to receive either 1)XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or 2) FOLFOX-4 (oxaliplatin + leucovorin + 5-FU in 2 week cycles. The anticipated time on study treatment is until disease progression, and the target sample size is 500+ individuals.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
, Bakersfield, California, United States
, Colorado Springs, Colorado, United States
, Washington, District of Columbia, United States
, Terre Haute, Indiana, United States
, St Louis, Missouri, United States
, Billings, Montana, United States
, Nyack, New York, United States
, Dallas, Texas, United States
, Bruxelles, , Belgium
, Bruxelles, , Belgium
, Gent, , Belgium
, Kortrijk, , Belgium
, Mont-godinne, , Belgium
, Edmonton, Alberta, Canada
, St. John's, Newfoundland and Labrador, Canada
, Halifax, Nova Scotia, Canada
, London, Ontario, Canada
, Oshawa, Ontario, Canada
, Ottawa, Ontario, Canada
, Saint Catherines, Ontario, Canada
, Thunder Bay, Ontario, Canada
, Toronto, Ontario, Canada
, Weston, Ontario, Canada
, Laval, Quebec, Canada
, Levis, Quebec, Canada
, Montreal, Quebec, Canada
, Montreal, Quebec, Canada
, Montreal, Quebec, Canada
, Quebec City, Quebec, Canada
, Regina, Saskatchewan, Canada
, Split, , Croatia
, Zagreb, , Croatia
, Tampere, , Finland
, Turku, , Finland
, Avignon, , France
, Bordeaux, , France
, Bordeaux, , France
, Chambray-lès-tours, , France
, Limoges, , France
, Nimes, , France
, Pessac, , France
, Rouen, , France
, Tübingen, , Germany
, Heraklion, , Greece
, Thessaloniki, , Greece
, Beer Sheva, , Israel
, Jerusalem, , Israel
, Kfar Saba, , Israel
, Petach Tikva, , Israel
, Ramat-gan, , Israel
, Rehovot, , Israel
, Tel Aviv, , Israel
, Bergamo, , Italy
, Cattolica, , Italy
, Rimini, , Italy
, Udine, , Italy
, Buchun, , Korea, Republic of
, Seoul, , Korea, Republic of
, Seoul, , Korea, Republic of
, Seoul, , Korea, Republic of
, Seoul, , Korea, Republic of
, Seoul, , Korea, Republic of
, Bialystok, , Poland
, Krakow, , Poland
, Warszawa, , Poland
, Warszawa, , Poland
, San Juan, , Puerto Rico
, Belgrade, , Serbia
, Bratislava, , Slovakia
, Ljubljana, , Slovenia
, Cape Town, , South Africa
, Durban, , South Africa
, Pietermaritzburg, , South Africa
, Port Elizabeth, , South Africa
, Pretoria, , South Africa
, Barcelona, , Spain
, Leganes, , Spain
, Madrid, , Spain
, Madrid, , Spain
, Palma de Mallorca, , Spain
, Kueishan, , Taiwan
, Tainan, , Taiwan
, Taipei, , Taiwan
, Denbigh, , United Kingdom
, Manchester, , United Kingdom
, Merseyside, , United Kingdom
, Preston, , United Kingdom
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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