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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/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 - 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).
Timepoint [1] 0 0
Approximately 3 years
Secondary outcome [1] 0 0
Relapse-Free Survival - 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.
Timepoint [1] 0 0
Approximately 3 years
Secondary outcome [2] 0 0
Overall Survival - 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).
Timepoint [2] 0 0
Approximately 3 years
Secondary outcome [3] 0 0
Mean Change From Baseline in Global Health Status at Week 25 - 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.
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 - 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.
Timepoint [4] 0 0
Up to Week 25
Secondary outcome [5] 0 0
Number of Participants With Any Adverse Events and Serious Adverse Events - 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.
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
Gender
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
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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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Hall in Tirol
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Innsbruck
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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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Bruxelles
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Napoli
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Zürich
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Belfast
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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
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.
Trial website
https://clinicaltrials.gov/show/NCT00009737
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

Summary results
Other publications