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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
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
Secondary ID [1] 0 0
M66001
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease-free Survival
Timepoint [1] 0 0
Approximately 3 years
Secondary outcome [1] 0 0
Relapse-Free Survival
Timepoint [1] 0 0
Approximately 3 years
Secondary outcome [2] 0 0
Overall Survival
Timepoint [2] 0 0
Approximately 3 years
Secondary outcome [3] 0 0
Mean Change From Baseline in Global Health Status at Week 25
Timepoint [3] 0 0
Baseline (Days -7 to 1) and at Week 25
Secondary outcome [4] 0 0
Number of Participants With Abnormalities for Blood Chemistry and Hematological Parameters
Timepoint [4] 0 0
Up to Week 25
Secondary outcome [5] 0 0
Number of Participants With Any Adverse Events and Serious Adverse Events
Timepoint [5] 0 0
Up to Week 29

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.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* previous chemotherapy

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/1998
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/04/2004
Sample size
Target
Accrual to date
Final
1987
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Adelaide
Recruitment hospital [2] 0 0
- Bendigo
Recruitment hospital [3] 0 0
- Brisbane
Recruitment hospital [4] 0 0
- Fitzroy
Recruitment hospital [5] 0 0
- Kurralta Park
Recruitment hospital [6] 0 0
- Melbourne
Recruitment hospital [7] 0 0
- Perth
Recruitment hospital [8] 0 0
- Port Macquarie
Recruitment hospital [9] 0 0
- St. Leonards
Recruitment hospital [10] 0 0
- Sydney
Recruitment hospital [11] 0 0
- Wodonga
Recruitment postcode(s) [1] 0 0
5011 - Adelaide
Recruitment postcode(s) [2] 0 0
3550 - Bendigo
Recruitment postcode(s) [3] 0 0
4006 - Brisbane
Recruitment postcode(s) [4] 0 0
3065 - Fitzroy
Recruitment postcode(s) [5] 0 0
5037 - Kurralta Park
Recruitment postcode(s) [6] 0 0
3128 - Melbourne
Recruitment postcode(s) [7] 0 0
3181 - Melbourne
Recruitment postcode(s) [8] 0 0
6000 - Perth
Recruitment postcode(s) [9] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [10] 0 0
2065 - St. Leonards
Recruitment postcode(s) [11] 0 0
2217 - Sydney
Recruitment postcode(s) [12] 0 0
3690 - Wodonga
Recruitment outside Australia
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United States of America
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Alabama
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Connecticut
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Tennessee
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Texas
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Washington
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Argentina
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Buenos Aires
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Austria
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Hall in Tirol
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Austria
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Innsbruck
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Austria
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Klagenfurt
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Linz
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Oberwart
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St Pölten
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Wien
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Bruxelles
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Belfast
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Manchester
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Newcastle Upon Tyne
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Northwood
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Plymouth
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Salisbury
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Southampton

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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