A Study of Xeloda (Capecitabine) Compared With 5-Fluorouracil in Combination With Low-Dose Leucovorin in Patients Who Have Undergone Surgery for Colon Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

1,987

Participants

Timeline

Start Date

November 30, 1998

Primary Completion Date

April 30, 2004

Study Completion Date

April 30, 2004

Conditions
Colorectal Cancer
Interventions
DRUG

5-Fluorouracil

425mg/m2 iv daily from day 1 to day 5 every 28 days.

DRUG

Leucovorin

20mg/m2 iv daily from day 1 to day 5 every 28 days.

DRUG

Capecitabine [Xeloda]

1250mg/m2 po bid on days 1-14 every 21 days.

Trial Locations (133)

1030

Vienna

1090

Vienna

Brussels

1100

Vienna

1160

Vienna

1220

Vienna

1417

Buenos Aires

1425

Buenos Aires

2065

St Leonards

2217

Sydney

2444

Port Macquarie

3010

Bern

3065

Fitzroy

3100

Sankt Pölten

3128

Melbourne

3181

Melbourne

3550

Bendigo

3690

Wodonga

4006

Brisbane

4010

Linz

4031

Basel

4070

Basel

5011

Adelaide

5037

Kurralta Park

6000

Perth

6020

Innsbruck

6060

Hall in Tirol

6500

Bellinzona

7400

Oberwart

8091

Zurich

9006

Sankt Gallen

9026

Klagenfurt

10123

Torino

10126

Torino

12100

Cuneo

12208

Albany

13353

Berlin

14004

Córdoba

14263

Buffalo

16132

Genova

19104

Philadelphia

20121

Milan

23007

Jaén

24128

Bergamo

26121

Oldenburg

26133

Oldenburg

28006

Madrid

28007

Madrid

28040

Madrid

28222

Madrid

30033

Decatur

30035

Mirano

30120

El Palmar Murcia

30122

Venezia

30171

Hanover

31008

Navarra

31275

Lehrte

33081

Aviano

33176

Miami

34125

Kassel

34354

Haifa

35294

Birmingham

36100

Vicenza

37073

Göttingen

38100

Braunschweig

39130

Magdeburg

40138

Bologna

41100

Modena

42210

Wuppertal

44195

Cleveland

46010

Valencia

46100

Mantova

47100

Vecchiazzano

48013

Bilbao

49100

Petah Tikva

56100

Pisa

57100

Livorno

63141

St Louis

65203

Columbia

75701

Tyler

76100

Rehovot

78052

Villingen-Schwenningen

78705

Austin

79106

Freiburg im Breisgau

79639

Grenzach-Wyhlen

80131

Napoli

81245

München

85012

Phoenix

88212

Ravensburg

90089

Los Angeles

92708

Fountain Valley

93053

Regensburg

98195

Seattle

6423906

Tel Aviv

06102-5037

Hartford

37203-1632

Nashville

C1264AAA

Buenos Aires

C1270AAE

Buenos Aires

90020-090

Porto Alegre

20220-410

Rio de Janeiro

01406100

São Paulo

18035-300

Sorocaba

T2N 4N2

Calgary

V1Y 5L3

Kelowna

R2H 2A6

Winnipeg

K1H 8L6

Ottawa

H3G 1A4

Montreal

S7N 4H4

Saskatoon

06108

Halle

Unknown

Petah Tikva

Roma

00135

Roma

00168

Roma

05100

Terni

1649-035

Lisbon

4200-072

Porto

03203

Elche

07014

Palma de Mallorca

AB25 2ZN

Aberdeen

BT9 7AB

Belfast

CF14 2TL

Cardiff

EH4 2XU

Edinburgh

G12 0YN

Glasgow

G4 OSF

Glasgow

GU2 7XX

Guildford

LE1 5WW

Leicester

LU4 0DZ

Luton

M20 4BX

Manchester

NE4 6BE

Newcastle upon Tyne

HA6 2RN

Northwood

PL6 8DH

Plymouth

SP2 8BJ

Salisbury

SO9 4PE

Southampton

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

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 | Biotech Hunter | Biotech Hunter