Clinical trial NCT00009737: A Study of Xeloda (Capecitabine) Compared With 5-Fluorouracil in Combination With Low-Dose Leucovorin in Patients Who Have Undergone Surgery for Colon Cancer
Official title: An Open-Label Randomized Phase III Study Comparing Xeloda (Capecitabine) With IV Bolus 5-Fluorouracil in Combination With Low-Dose Leucovorin as Adjuvant Chemotherapy in Patients Who Underwent Surgery for Dukes C Colon Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2004-03-17
Enrollment: 1987
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This 2 arm study will compare the safety and efficacy of oral Xeloda, or 5-fluorouracil in combination with leucovorin, in patients who have undergone surgery for colon cancer. Patients will be randomized to receive either Xeloda 1250mg/m2 po bid on days 1-14 every 21 days, or leucovorin 20mg/m2 iv + 5-fluorouracil 425mg/m2 iv daily from day 1 to day 5 every 28 days. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients 18-75 years of age;
* histologically confirmed colon cancer with potentially curative resection of the tumor within 8 weeks before study initiation.

Exclusion Criteria:

* previous chemotherapy

Primary outcomes:
measure: Disease-free Survival
timeFrame: Approximately 3 years
Secondary outcomes:
measure: Relapse-Free Survival
timeFrame: Approximately 3 years
measure: Overall Survival
timeFrame: Approximately 3 years
measure: Mean Change From Baseline in Global Health Status at Week 25
timeFrame: Baseline (Days -7 to 1) and at Week 25
measure: Number of Participants With Abnormalities for Blood Chemistry and Hematological Parameters
timeFrame: Up to Week 25
measure: Number of Participants With Any Adverse Events and Serious Adverse Events
timeFrame: Up to Week 29
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: Fountain Valley
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Hartford
country: United States
state: Connecticut
city: Miami
country: United States
state: Florida
city: Decatur
country: United States
state: Georgia
city: Columbia
country: United States
state: Missouri
city: St Louis
country: United States
state: Missouri
city: Albany
country: United States
state: New York
city: Buffalo
country: United States
state: New York
city: Cleveland
country: United States
state: Ohio
city: Philadelphia
country: United States
state: Pennsylvania
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: Tyler
country: United States
state: Texas
city: Seattle
country: United States
state: Washington
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Buenos Aires
country: Argentina
city: Adelaide
country: Australia
city: Bendigo
country: Australia
city: Brisbane
country: Australia
city: Fitzroy
country: Australia
city: Kurralta Park
country: Australia
city: Melbourne
country: Australia
city: Melbourne
country: Australia
city: Perth
country: Australia
city: Port Macquarie
country: Australia
city: St. Leonards
country: Australia
city: Sydney
country: Australia
city: Wodonga
country: Australia
city: Hall in Tirol
country: Austria
city: Innsbruck
country: Austria
city: Klagenfurt
country: Austria
city: Linz
country: Austria
city: Oberwart
country: Austria
city: St Pölten
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Wien
country: Austria
city: Bruxelles
country: Belgium
city: Porto Alegre
country: Brazil
city: Rio de Janeiro
country: Brazil
city: Sao Paulo
country: Brazil
city: Sorocaba
country: Brazil
city: Calgary
country: Canada
state: Alberta
city: Kelowna
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Ottawa
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Saskatoon
country: Canada
state: Saskatchewan
city: Berlin
country: Germany
city: Braunschweig
country: Germany
city: Freiburg
country: Germany
city: Grenzach-wyhlen
country: Germany
city: Göttingen
country: Germany
city: Halle
country: Germany
city: Hannover
country: Germany
city: Kassel
country: Germany
city: Lehrte
country: Germany
city: Magdeburg
country: Germany
city: München
country: Germany
city: Oldenburg
country: Germany
city: Oldenburg
country: Germany
city: Ravensburg
country: Germany
city: Regensburg
country: Germany
city: Villingen-schwenningen
country: Germany
city: Wuppertal
country: Germany
city: Haifa
country: Israel
city: Petach Tikva
country: Israel
city: Petach Tikva
country: Israel
city: Rehovot
country: Israel
city: Tel Aviv
country: Israel
city: Aviano
country: Italy
city: Bergamo
country: Italy
city: Bologna
country: Italy
city: Cuneo
country: Italy
city: Genova
country: Italy
city: Livorno
country: Italy
city: Mantova
country: Italy
city: Milano
country: Italy
city: Mirano
country: Italy
city: Modena
country: Italy
city: Napoli
country: Italy
city: Pisa
country: Italy
city: Roma
country: Italy
city: Roma
country: Italy
city: Roma
country: Italy
city: Terni
country: Italy
city: Torino
country: Italy
city: Torino
country: Italy
city: Vecchiazzano
country: Italy
city: Venezia
country: Italy
city: Vicenza
country: Italy
city: Lisboa
country: Portugal
city: Porto
country: Portugal
city: Bilbao
country: Spain
city: Cordoba
country: Spain
city: El Palmar Murcia
country: Spain
city: Elche
country: Spain
city: Jaen
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Navarra
country: Spain
city: Palma de Mallorca
country: Spain
city: Valencia
country: Spain
city: Basel
country: Switzerland
city: Basel
country: Switzerland
city: Bellinzona
country: Switzerland
city: Bern
country: Switzerland
city: St Gallen
country: Switzerland
city: Zürich
country: Switzerland
city: Aberdeen
country: United Kingdom
city: Belfast
country: United Kingdom
city: Cardiff
country: United Kingdom
city: Edinburgh
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Guildford
country: United Kingdom
city: Leicester
country: United Kingdom
city: Luton
country: United Kingdom
city: Manchester
country: United Kingdom
city: Newcastle Upon Tyne
country: United Kingdom
city: Northwood
country: United Kingdom
city: Plymouth
country: United Kingdom
city: Salisbury
country: United Kingdom
city: Southampton
country: United Kingdom
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: