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Trial information
A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer
Status: No longer recruiting
Protocol number: NO16968
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, open-label study of the effect of intermittent Xeloda in combination with Eloxatin, versus fluorouracil/leucovorin, on disease-free survival in patients who have undergone surgery for colon cancer.2
Brief summary: This 2 arm study will compare the efficacy and safety of intermittent oral Xeloda plus Eloxatin (oxaliplatin) with that of fluorouracil/leucovorin in patients who have had surgery for colon cancer and no previous chemotherapy. 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)5-fluorouracil + leucovorin in 4 or 8 week cycles. The anticipated time on study treatment is until disease progression and the target sample size is 500+ individuals.
Target sample size is 1886.
Study phase: III
Study type: Interventional; Treatment; Randomized; Open Label; Active; Parallel; Safety/Efficacy study
Condition: Colorectal Cancer
Intervention type: Drug
Intervention name: capecitabine [Xeloda]
Primary outcome: 1. Superiority in disease-free survival Time frame: Event driven
Key secondary outcomes: 1. Adverse events, laboratory parameters. Time frame: Throughout study
Inclusion criteria: - adult patients >=18 years of age;
- colon cancer;
- complete tumor resection.
Exclusion criteria: - prior treatment with cytotoxic chemotherapy, radiotherapy, or immunotherapy for the currently treated colon cancer.
Gender: Males or Females
Age limits: Min: 18 Years Max: N/A (No limit)
Accepts healthy volunteers: No
Anticipated start date: April, 2003
Trial registration date: 06/24/2005
Date last updated: 8/19/2008
Link to trial result
This trial was conducted at the following locations:Australia - Adelaide
- Melbourne
- Perth
- Port Macquarie
- Sydney
- Wollongong
Belgium - Bruxelles
- Charleroi
- Gent
- Kortrijk
- Leuven
Brazil - Belo Horizonte
- Jaú
- Sao Paulo
Canada - Calgary, AB
- Edmonton, AB
- Kelowna, BC
- Surrey, BC
- Victoria, BC
- Winnipeg, MB
- St John'S
- Halifax, NS
- Hamilton, ON
- London, ON
- Mississauga, ON
- Oshawa, ON
- Ottawa, ON
- Toronto, ON
- Weston, ON
- Laval, QC
- Levis, QC
- Montreal, QC
- Quebec City, QC
China - Beijing
- Guangdong
- Hangzhou
- Hong Kong
- Jiangsu
- Jiangxi
- Shanghai
- Tianjin
- Wuhan
Finland France - Colmar
- Lille
- Marseille
- Strasbourg
Germany - Freiburg
- Halle
- Magdeburg
- Trier
Greece - Athens
- Heraklion
- Patras
- Thessaloniki
Hungary Ireland Israel - Beer Sheva
- Haifa
- Jerusalem
- Kfar Saba
- Nahariya
- Petah Tikva
- Ramat Gan
- Rehovot
- Tel Aviv
- Zerifin
Italy - Ancona
- Bergamo
- Cattolica
- Genova
- Livorno
- Milano
- Parma
- Rimini
- Sassari
- Siena
- Udine
Korea, Republic of Mexico - Chihuahua
- Mexicali
- Mexico City
New Zealand - Auckland
- Christchurch
- Dunedin
- Palmerston North
- Wellington
Panama Poland - Krakow
- Lodz
- Poznan
- Szczecin
- Warszawa
- Zielona Gora
Portugal Russian Federation Singapore South Africa - Cape Town
- Durban
- Pietermaritzburg
- Pretoria
- Sandton
Spain - Barakaldo
- Barcelona
- Córdoba
- Elche
- Jaen
- Leganes
- Madrid
- Malaga
- Palma de Mallorca
- Santander
- Valencia
Switzerland Taiwan Thailand United Kingdom - Aberdeen
- Belfast
- Brighton
- Bury St Edmunds
- Cambridge
- Denbigh
- Derby
- Glasgow
- Guildford
- Leeds
- Leicester
- London
- Maidstone
- Manchester
- Middlesborough
- Newcastle upon Tyne
- Northwood
- Nottingham
- Plymouth
- Salisbury
- Southampton
- Sutton
United States - Mobile, AL
- Alhambra, CA
- Bakersfield, CA
- Fullerton, CA
- Long Beach, CA
- Los Angeles, CA
- Northridge, CA
- Oxnard, CA
- Pomona, CA
- Sacramento, CA
- San Diego , CA
- Santa Barbara, CA
- Vista, CA
- Denver, CO
- Fort Collins, CO
- Stamford, CT
- Washington, DC
- Lakeland, FL
- Miami, FL
- Atlanta, GA
- Peoria, IL
- Terre Haute, IN
- New Orleans, LA
- St Louis Park, MN
- St Joseph, MO
- St Louis, MO
- Billings, MT
- Reno , NV
- Hooksett, NH
- Morristown, NJ
- Summit, NJ
- Albuquerque, NM
- New York, NY
- Charlotte, NC
- Greensboro, NC
- Hickory , NC
- Bethlehem, PA
- Kingston , PA
- Philadelphia, PA
- Pittsburgh, PA
- Memphis , TN
- Fort Worth, TX
- Salt Lake City, UT
- Yakima, WA
- Madison, WI
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