Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00009737
Registration number
NCT00009737
Ethics application status
Date submitted
2/02/2001
Date registered
17/03/2004
Date last updated
22/06/2016
Titles & IDs
Public title
A Study of Xeloda (Capecitabine) Compared With 5-Fluorouracil in Combination With Low-Dose Leucovorin in Patients Who Have Undergone Surgery for Colon Cancer
Query!
Scientific 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
Query!
Secondary ID [1]
0
0
M66001
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer
0
0
Query!
Condition category
Condition code
Cancer
0
0
0
0
Query!
Bowel - Back passage (rectum) or large bowel (colon)
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Treatment: Drugs - 5-Fluorouracil
Treatment: Drugs - Leucovorin
Treatment: Drugs - Capecitabine [Xeloda]
Experimental: Capecitabine - Participants received capecitabine 1250 milligram per square meter (mg/m \^ 2) orally, twice a day, for 14 days, followed by a 7-day rest period without treatment, as an intermittent therapy in a 3-week cycle for 8 cycles (24 weeks).
Active comparator: 5-Fluorouracil + Leucovorin - Participants received leucovorin 20 mg/m \^ 2 followed by 5-fluorouracil at 425 mg/m \^ 2, by rapid intravenous injection, daily, from Days 1 to 5 of the first week in each 4-week cycle for 6 cycles (24 weeks).
Treatment: Drugs: 5-Fluorouracil
425mg/m2 iv daily from day 1 to day 5 every 28 days.
Treatment: Drugs: Leucovorin
20mg/m2 iv daily from day 1 to day 5 every 28 days.
Treatment: Drugs: Capecitabine [Xeloda]
1250mg/m2 po bid on days 1-14 every 21 days.
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Disease-free Survival
Query!
Assessment method [1]
0
0
Participants with disease-free survival were reported. Disease-free survival was assessed as the number of days between randomization and the first time at which relapse, a new occurrence of colon cancer, or death was recorded, or the last time at which a participant was known to be disease free (censoring time).
Query!
Timepoint [1]
0
0
Approximately 3 years
Query!
Secondary outcome [1]
0
0
Relapse-Free Survival
Query!
Assessment method [1]
0
0
Participants with relapse-free survival were reported. Relapse-free survival was assessed as the number of days between randomization and the first time at which relapse, a new occurrence of colon cancer, or death was recorded, or the last time at which a participants was known to be disease free (censoring time), excluding deaths that were not related to treatment or to disease progression.
Query!
Timepoint [1]
0
0
Approximately 3 years
Query!
Secondary outcome [2]
0
0
Overall Survival
Query!
Assessment method [2]
0
0
Participants with overall survival were reported. Overall survival was assessed as the number of days between randomization and death or the last time at which a participant was known to be alive (censoring time).
Query!
Timepoint [2]
0
0
Approximately 3 years
Query!
Secondary outcome [3]
0
0
Mean Change From Baseline in Global Health Status at Week 25
Query!
Assessment method [3]
0
0
Global health status was assessed as a sub scale of European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30. It was scored on a scale of 0-100; where higher score indicates better quality of life. Wherever the scores for the participants were not available, the last value carried forward (LVCF) were used.
Query!
Timepoint [3]
0
0
Baseline (Days -7 to 1) and at Week 25
Query!
Secondary outcome [4]
0
0
Number of Participants With Abnormalities for Blood Chemistry and Hematological Parameters
Query!
Assessment method [4]
0
0
Laboratory abnormalities were categorized according to the National Cancer Institute of Canada Common Toxicity Criteria (NCIC - CTC) grading system (May 1991 revised) as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (life- threatening). Participants with abnormalities in hemoglobin, granulocytes, lymphocytes, neutrophils, neutrophils/granulocytes, platelets, white blood cell, potassium, serum creatinine, sodium, total bilirubin, alanine transaminase, aspartate aminotransferase, alkaline phosphatase, calcium (hyper), and calcium (hypo) with Grades 1-4 were presented.
Query!
Timepoint [4]
0
0
Up to Week 25
Query!
Secondary outcome [5]
0
0
Number of Participants With Any Adverse Events and Serious Adverse Events
Query!
Assessment method [5]
0
0
An Adverse Event (AE) is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An Serious Adverse Events (SAEs) is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.
Query!
Timepoint [5]
0
0
Up to Week 29
Query!
Eligibility
Key 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.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
75
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* previous chemotherapy
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 3
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/11/1998
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/04/2004
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
1987
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment hospital [1]
0
0
- Adelaide
Query!
Recruitment hospital [2]
0
0
- Bendigo
Query!
Recruitment hospital [3]
0
0
- Brisbane
Query!
Recruitment hospital [4]
0
0
- Fitzroy
Query!
Recruitment hospital [5]
0
0
- Kurralta Park
Query!
Recruitment hospital [6]
0
0
- Melbourne
Query!
Recruitment hospital [7]
0
0
- Perth
Query!
Recruitment hospital [8]
0
0
- Port Macquarie
Query!
Recruitment hospital [9]
0
0
- St. Leonards
Query!
Recruitment hospital [10]
0
0
- Sydney
Query!
Recruitment hospital [11]
0
0
- Wodonga
Query!
Recruitment postcode(s) [1]
0
0
5011 - Adelaide
Query!
Recruitment postcode(s) [2]
0
0
3550 - Bendigo
Query!
Recruitment postcode(s) [3]
0
0
4006 - Brisbane
Query!
Recruitment postcode(s) [4]
0
0
3065 - Fitzroy
Query!
Recruitment postcode(s) [5]
0
0
5037 - Kurralta Park
Query!
Recruitment postcode(s) [6]
0
0
3128 - Melbourne
Query!
Recruitment postcode(s) [7]
0
0
3181 - Melbourne
Query!
Recruitment postcode(s) [8]
0
0
6000 - Perth
Query!
Recruitment postcode(s) [9]
0
0
2444 - Port Macquarie
Query!
Recruitment postcode(s) [10]
0
0
2065 - St. Leonards
Query!
Recruitment postcode(s) [11]
0
0
2217 - Sydney
Query!
Recruitment postcode(s) [12]
0
0
3690 - Wodonga
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Alabama
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
Arizona
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
California
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Connecticut
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Florida
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Georgia
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
Missouri
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
New York
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
Ohio
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Pennsylvania
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Tennessee
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
Texas
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Washington
Query!
Country [14]
0
0
Argentina
Query!
State/province [14]
0
0
Buenos Aires
Query!
Country [15]
0
0
Austria
Query!
State/province [15]
0
0
Hall in Tirol
Query!
Country [16]
0
0
Austria
Query!
State/province [16]
0
0
Innsbruck
Query!
Country [17]
0
0
Austria
Query!
State/province [17]
0
0
Klagenfurt
Query!
Country [18]
0
0
Austria
Query!
State/province [18]
0
0
Linz
Query!
Country [19]
0
0
Austria
Query!
State/province [19]
0
0
Oberwart
Query!
Country [20]
0
0
Austria
Query!
State/province [20]
0
0
St Pölten
Query!
Country [21]
0
0
Austria
Query!
State/province [21]
0
0
Wien
Query!
Country [22]
0
0
Belgium
Query!
State/province [22]
0
0
Bruxelles
Query!
Country [23]
0
0
Brazil
Query!
State/province [23]
0
0
Porto Alegre
Query!
Country [24]
0
0
Brazil
Query!
State/province [24]
0
0
Rio de Janeiro
Query!
Country [25]
0
0
Brazil
Query!
State/province [25]
0
0
Sao Paulo
Query!
Country [26]
0
0
Brazil
Query!
State/province [26]
0
0
Sorocaba
Query!
Country [27]
0
0
Canada
Query!
State/province [27]
0
0
Alberta
Query!
Country [28]
0
0
Canada
Query!
State/province [28]
0
0
British Columbia
Query!
Country [29]
0
0
Canada
Query!
State/province [29]
0
0
Manitoba
Query!
Country [30]
0
0
Canada
Query!
State/province [30]
0
0
Ontario
Query!
Country [31]
0
0
Canada
Query!
State/province [31]
0
0
Quebec
Query!
Country [32]
0
0
Canada
Query!
State/province [32]
0
0
Saskatchewan
Query!
Country [33]
0
0
Germany
Query!
State/province [33]
0
0
Berlin
Query!
Country [34]
0
0
Germany
Query!
State/province [34]
0
0
Braunschweig
Query!
Country [35]
0
0
Germany
Query!
State/province [35]
0
0
Freiburg
Query!
Country [36]
0
0
Germany
Query!
State/province [36]
0
0
Grenzach-wyhlen
Query!
Country [37]
0
0
Germany
Query!
State/province [37]
0
0
Göttingen
Query!
Country [38]
0
0
Germany
Query!
State/province [38]
0
0
Halle
Query!
Country [39]
0
0
Germany
Query!
State/province [39]
0
0
Hannover
Query!
Country [40]
0
0
Germany
Query!
State/province [40]
0
0
Kassel
Query!
Country [41]
0
0
Germany
Query!
State/province [41]
0
0
Lehrte
Query!
Country [42]
0
0
Germany
Query!
State/province [42]
0
0
Magdeburg
Query!
Country [43]
0
0
Germany
Query!
State/province [43]
0
0
München
Query!
Country [44]
0
0
Germany
Query!
State/province [44]
0
0
Oldenburg
Query!
Country [45]
0
0
Germany
Query!
State/province [45]
0
0
Ravensburg
Query!
Country [46]
0
0
Germany
Query!
State/province [46]
0
0
Regensburg
Query!
Country [47]
0
0
Germany
Query!
State/province [47]
0
0
Villingen-schwenningen
Query!
Country [48]
0
0
Germany
Query!
State/province [48]
0
0
Wuppertal
Query!
Country [49]
0
0
Israel
Query!
State/province [49]
0
0
Haifa
Query!
Country [50]
0
0
Israel
Query!
State/province [50]
0
0
Petach Tikva
Query!
Country [51]
0
0
Israel
Query!
State/province [51]
0
0
Rehovot
Query!
Country [52]
0
0
Israel
Query!
State/province [52]
0
0
Tel Aviv
Query!
Country [53]
0
0
Italy
Query!
State/province [53]
0
0
Aviano
Query!
Country [54]
0
0
Italy
Query!
State/province [54]
0
0
Bergamo
Query!
Country [55]
0
0
Italy
Query!
State/province [55]
0
0
Bologna
Query!
Country [56]
0
0
Italy
Query!
State/province [56]
0
0
Cuneo
Query!
Country [57]
0
0
Italy
Query!
State/province [57]
0
0
Genova
Query!
Country [58]
0
0
Italy
Query!
State/province [58]
0
0
Livorno
Query!
Country [59]
0
0
Italy
Query!
State/province [59]
0
0
Mantova
Query!
Country [60]
0
0
Italy
Query!
State/province [60]
0
0
Milano
Query!
Country [61]
0
0
Italy
Query!
State/province [61]
0
0
Mirano
Query!
Country [62]
0
0
Italy
Query!
State/province [62]
0
0
Modena
Query!
Country [63]
0
0
Italy
Query!
State/province [63]
0
0
Napoli
Query!
Country [64]
0
0
Italy
Query!
State/province [64]
0
0
Pisa
Query!
Country [65]
0
0
Italy
Query!
State/province [65]
0
0
Roma
Query!
Country [66]
0
0
Italy
Query!
State/province [66]
0
0
Terni
Query!
Country [67]
0
0
Italy
Query!
State/province [67]
0
0
Torino
Query!
Country [68]
0
0
Italy
Query!
State/province [68]
0
0
Vecchiazzano
Query!
Country [69]
0
0
Italy
Query!
State/province [69]
0
0
Venezia
Query!
Country [70]
0
0
Italy
Query!
State/province [70]
0
0
Vicenza
Query!
Country [71]
0
0
Portugal
Query!
State/province [71]
0
0
Lisboa
Query!
Country [72]
0
0
Portugal
Query!
State/province [72]
0
0
Porto
Query!
Country [73]
0
0
Spain
Query!
State/province [73]
0
0
Bilbao
Query!
Country [74]
0
0
Spain
Query!
State/province [74]
0
0
Cordoba
Query!
Country [75]
0
0
Spain
Query!
State/province [75]
0
0
El Palmar Murcia
Query!
Country [76]
0
0
Spain
Query!
State/province [76]
0
0
Elche
Query!
Country [77]
0
0
Spain
Query!
State/province [77]
0
0
Jaen
Query!
Country [78]
0
0
Spain
Query!
State/province [78]
0
0
Madrid
Query!
Country [79]
0
0
Spain
Query!
State/province [79]
0
0
Navarra
Query!
Country [80]
0
0
Spain
Query!
State/province [80]
0
0
Palma de Mallorca
Query!
Country [81]
0
0
Spain
Query!
State/province [81]
0
0
Valencia
Query!
Country [82]
0
0
Switzerland
Query!
State/province [82]
0
0
Basel
Query!
Country [83]
0
0
Switzerland
Query!
State/province [83]
0
0
Bellinzona
Query!
Country [84]
0
0
Switzerland
Query!
State/province [84]
0
0
Bern
Query!
Country [85]
0
0
Switzerland
Query!
State/province [85]
0
0
St Gallen
Query!
Country [86]
0
0
Switzerland
Query!
State/province [86]
0
0
Zürich
Query!
Country [87]
0
0
United Kingdom
Query!
State/province [87]
0
0
Aberdeen
Query!
Country [88]
0
0
United Kingdom
Query!
State/province [88]
0
0
Belfast
Query!
Country [89]
0
0
United Kingdom
Query!
State/province [89]
0
0
Cardiff
Query!
Country [90]
0
0
United Kingdom
Query!
State/province [90]
0
0
Edinburgh
Query!
Country [91]
0
0
United Kingdom
Query!
State/province [91]
0
0
Glasgow
Query!
Country [92]
0
0
United Kingdom
Query!
State/province [92]
0
0
Guildford
Query!
Country [93]
0
0
United Kingdom
Query!
State/province [93]
0
0
Leicester
Query!
Country [94]
0
0
United Kingdom
Query!
State/province [94]
0
0
Luton
Query!
Country [95]
0
0
United Kingdom
Query!
State/province [95]
0
0
Manchester
Query!
Country [96]
0
0
United Kingdom
Query!
State/province [96]
0
0
Newcastle Upon Tyne
Query!
Country [97]
0
0
United Kingdom
Query!
State/province [97]
0
0
Northwood
Query!
Country [98]
0
0
United Kingdom
Query!
State/province [98]
0
0
Plymouth
Query!
Country [99]
0
0
United Kingdom
Query!
State/province [99]
0
0
Salisbury
Query!
Country [100]
0
0
United Kingdom
Query!
State/province [100]
0
0
Southampton
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Hoffmann-La Roche
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT00009737
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Clinical Trials
Query!
Address
0
0
Hoffmann-La Roche
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00009737
Download to PDF