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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00069121




Trial ID
NCT00069121
Ethics application status
Date submitted
15/09/2003
Date registered
17/09/2003
Date last updated
13/08/2013

Titles & IDs
Public title
A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer
Scientific title
A Randomized, Open-label Study of the Effect of Intermittent Xeloda in Combination With Eloxatin, Versus Fluorouracil/Leucovorin, on Disease-free Survival in Patients Who Have Undergone Surgery for Colon Cancer.
Secondary ID [1] 0 0
NO16968
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 - capecitabine [Xeloda]
Treatment: Drugs - Oxaliplatin
Treatment: Drugs - Oxaliplatin
Treatment: Drugs - Leucovorin
Treatment: Drugs - 5 FU

Experimental: 1 -

Active Comparator: 2 -


Treatment: Drugs: capecitabine [Xeloda]
1000mg/m2 iv bid on days 1-15 of each 3 week cycle

Treatment: Drugs: Oxaliplatin
As prescribed, in 3 week cycles

Treatment: Drugs: Oxaliplatin
As prescribed, in 2 week cycles

Treatment: Drugs: Leucovorin
As prescribed, in 2 week cycles.

Treatment: Drugs: 5 FU
As prescribed, in 2 week cycles

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Disease-free Survival (DFS) [Number of Events] - Number of patients with/without recurrence of the original colon cancer or appearance of a new colon or rectal cancer, or death due to any cause. Based on tumor assessments and survival follow-up assessments.
Timepoint [1] 0 0
Time from randomization date to date of first event/date last known to be event free. Median observation time for DFS was approx 57 mos.
Primary outcome [2] 0 0
Disease-free Survival [Time to Event] - Determination of an event was based on tumor assessments and survival follow-up assessments. Any recurrence of the original colon cancer or appearance of a new colon or rectal cancer was to be proven by cytology or histology, when possible. An isolated event of increased CEA, or unexplained clinical deterioration were not considered to be evidence of relapse without support of other objective measurements. The date of relapse was defined as the date of the definitive assessment by objective measurements.
Timepoint [2] 0 0
Time from randomization date to date of first event/date last known to be event free. Median observation time for DFS was approx 57 mos.
Secondary outcome [1] 0 0
Relapse-free Survival (RFS) [Number of Events] - Included only recurrence of the original colon cancer, development of a new colon or rectal cancer, and deaths related to any of the following: treatment, recurrence of the original colon cancer, or development of a new colon or rectal cancer.
Timepoint [1] 0 0
Time from randomization date to date of first event/date last known to be event free. Median observation time for RFS was approx 57 mos.
Secondary outcome [2] 0 0
Relapse-free Survival (RFS) [Time to Event] - Included only recurrence of the original colon cancer, development of a new colon or rectal cancer, and deaths related to any of the following: treatment, recurrence of the original colon cancer, or development of a new colon or rectal cancer. Patients who were not reported as having died at the time of the analysis were censored using the date they were last known to be relapse free.
Timepoint [2] 0 0
Time from randomization date to date of first event/date last known to be event free. Median observation time for RFS was approx 57 mos.
Secondary outcome [3] 0 0
Overall Survival [Number of Events] - Survival was measured as the time from randomization to the date of death, irrespective of the cause of death. Patients who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive.
Timepoint [3] 0 0
Time from randomization date to date of death/date last known to be alive. Median observation time for was approx 59 mos.
Secondary outcome [4] 0 0
Overall Survival [Time to Event] - Survival was measured as the time from randomization to the date of death, irrespective of the cause of death. Patients who were not reported as having died at the time of the analysis were censored using the date they were last known to be alive.
Timepoint [4] 0 0
Time from randomization date to date of death/date last known to be alive. Median observation time for was approx 59 mos.
Secondary outcome [5] 0 0
Number of Participants Assesed for Adverse Events - Adverse events were presented in individual listings and summarized by Medical Dictionary for Regulatory Activities (MedDRA)System Organ Classes, intensity, and relation to trial treatment. Laboratory data are summarized in two ways: Summary of laboratory abnormalities (regardless of the baseline values), with particular attention to the more clinically relevant Grade 3/4 laboratory abnormalities. Summary of laboratory abnormalities as a shift from baseline.
See Adverse Events module for details.
Timepoint [5] 0 0
followed from Time of Very First Drug Intake and 28 day(s) after Very Last Drug Intake

Eligibility
Key inclusion criteria
- adult patients >=18 years of age;

- colon cancer;

- complete tumor resection.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- prior treatment with cytotoxic chemotherapy, radiotherapy, or immunotherapy for the
currently treated colon cancer.

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
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- Adelaide
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- Camperdown
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- Melbourne
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- Perth
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- Port Macquarie
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- Wollongong
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5011 - Adelaide
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2050 - Camperdown
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3128 - Melbourne
Recruitment postcode(s) [4] 0 0
6008 - Perth
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2444 - Port Macquarie
Recruitment postcode(s) [6] 0 0
2500 - Wollongong
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Sutton

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 efficacy and safety of intermittent oral Xeloda plus
Eloxatin (oxaliplatin) with that of fluorouracil/leucovorin in patients who have had surgery
for colon cancer and no previous chemotherapy. Patients will be randomized to receive either
1) XELOX (Xeloda 1000mg/m2 po bid on days 1-15 + oxaliplatin) in 3 week cycles or
2)5-fluorouracil + leucovorin in 4 or 8 week cycles. The anticipated time on study treatment
is until disease progression and the target sample size is 500+ individuals.
Trial website
https://clinicaltrials.gov/show/NCT00069121
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