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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00069121
Registration number
NCT00069121
Ethics application status
Date submitted
15/09/2003
Date registered
18/09/2003
Date last updated
6/03/2020
Titles & IDs
Public title
A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer
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Scientific title
An Open-Label Randomized Phase III Study of Intermittent Oral Capecitabine in Combination With Intravenous Oxaliplatin (Q3W) ("XELOX") Versus Fluorouracil/Leucovorin as Adjuvant Therapy for Patients Who Have Undergone Surgery for Colon Carcinoma, AJCC/UICC Stage III (Dukes Stage C)
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Secondary ID [1]
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NO16968
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Colorectal Cancer
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Condition category
Condition code
Cancer
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Bowel - Back passage (rectum) or large bowel (colon)
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Capecitabine
Treatment: Drugs - Oxaliplatin
Treatment: Drugs - Leucovorin (LV)
Treatment: Drugs - 5-Fluorouracil (5-FU)
Active Comparator: 5-Fluorouracil/Leucovorin (5-FU/LV) - Participants were given one of two regimens (each participating center prespecified which regimen they would use for all patients at that center): i) Mayo Clinic regimen group: LV 20 mg/m^2 IV bolus injection + 5-FU 425 mg/m^2 IV bolus injection daily on Days 1-5 of a four-week cycle, for a total of six cycles (24 weeks), or; ii) Roswell Park regimen group: LV 500 mg/m^2 by two-hour IV infusion + 5-FU 500 mg/m^2 IV bolus injection one hour after the start of the LV infusion on Day 1 of Weeks 1 to 6 of each eight-week cycle, for a total of four cycles (32 weeks).
Experimental: Capecitabine in Combination with Oxaliplatin (XELOX) - Capecitabine was administered as an oral twice daily outpatient intermittent treatment (3-week cycles consisting of two weeks of treatment followed by one week without treatment) combined with intravenous (IV) oxaliplatin on Day 1 of each cycle. Capecitabine was administered orally at a dose of 1000 mg/m^2 twice-daily (equivalent to a total daily dose of 2000 mg/m^2) with the first dose given during the evening of Day 1 and last dose given during the morning of Day 15. Oxaliplatin was administered as a 130 mg/m^2 IV infusion over two hours on Day 1 of each cycle. The XELOX combination was administered for a total of eight cycles (24 weeks).
Treatment: Drugs: Capecitabine
1000 milligrams per square metre of body surface area (mg/m^2) orally twice daily on days 1-15 of each 3-week cycle.
Treatment: Drugs: Oxaliplatin
130 mg/m^2 intravenous (IV) infusion over two hours on Day 1 of each 3-week cycle.
Treatment: Drugs: Leucovorin (LV)
Administered by one of two regimens, as specified in the arm description.
Treatment: Drugs: 5-Fluorouracil (5-FU)
Administered by one of two regimens, as specified in the arm description.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Disease-Free Survival (DFS) [Number of Events]
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Assessment method [1]
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Determination of an event was based on tumor assessments and survival follow-up assessments. A disease-free survival (DFS) event was defined as any recurrence of the original colon cancer or appearance of a new colon or rectal cancer (proven by cytology or histology, when possible) or death due to any cause, whichever was earliest. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants with no tumor assessments after baseline were censored at Day 1. 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.
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Timepoint [1]
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Time from randomization date to date of first DFS event/date last known to be event-free. Median observation time for DFS was 74 months (range: 0-95 months).
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Primary outcome [2]
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Disease-Free Survival (DFS) [Time to Event]
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Assessment method [2]
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Determination of an event was based on tumor assessments and survival follow-up assessments. A disease-free survival (DFS) event was defined as any recurrence of the original colon cancer or appearance of a new colon or rectal cancer (proven by cytology or histology, when possible) or death due to any cause, whichever was earliest. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants with no tumor assessments after baseline were censored at Day 1. 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. The median was estimated by the Kaplan-Meier method. The full range values include censored observations.
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Timepoint [2]
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Time from randomization date to date of first DFS event/date last known to be event-free. Median observation time for DFS was 74 months (range: 0-95 months).
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Secondary outcome [1]
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Relapse-Free Survival (RFS) [Number of Events]
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Assessment method [1]
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A relapse-free survival (RFS) event included 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. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants whose cause of death was unrelated to treatment or disease recurrence were censored at the time of the last tumor assessment.
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Timepoint [1]
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Time from randomization date to date of first RFS event/date last known to be event-free. Median observation time for RFS was 74 months (range: 0-95 months).
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Secondary outcome [2]
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Relapse-Free Survival (RFS) [Time to Event]
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Assessment method [2]
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A relapse-free survival (RFS) event included 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. Participants who had not had any such event at the time of data analysis were censored at the last date they were known to be event-free. Participants whose cause of death was unrelated to treatment or disease recurrence were censored at the time of the last tumor assessment. The median was estimated by the Kaplan-Meier method. The full range values include censored observations.
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Timepoint [2]
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Time from randomization date to date of first RFS event/date last known to be event-free. Median observation time for RFS was 74 months (range: 0-95 months).
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Secondary outcome [3]
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Overall Survival [Number of Events]
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Assessment method [3]
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Overall survival was measured as the time from randomization to the date of death, irrespective of the cause of death. Participants 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.
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Timepoint [3]
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Time from randomization date to date of death/date last known to be alive. Median observation time was 83 months (range: 0-95 months).
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Secondary outcome [4]
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Overall Survival [Time to Event]
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Assessment method [4]
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Overall survival was measured as the time from randomization to the date of death, irrespective of the cause of death. Participants 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. The median was estimated by the Kaplan-Meier method. The full range values include censored observations.
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Timepoint [4]
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Time from randomization date to date of death/date last known to be alive. Median observation time was 83 months (range: 0-95 months).
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Secondary outcome [5]
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Number of Participants With at Least One Adverse Event by Most Severe Intensity
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Assessment method [5]
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The intensity of all adverse events (AEs) was categorized according to the National Cancer Institute Common Toxicity Criteria for Adverse Events (NCI CTCAE) (version 3.0) grading system. If an AE had occurred which was not contained in the NCI-CTC, a four-point scale (mild, moderate, severe, life-threatening) was used. The terms "severe" and "serious" are not synonymous and are independently assessed for each AE. Only the most severe intensity was counted for multiple occurrences of an AE in one individual. See the AEs results table for details.
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Timepoint [5]
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From time of very first drug intake to 28 days after very last drug intake (median [full range] duration of study treatment per arm: 5-FU/LV MAYO CLINIC: 145 [4-208] days; 5-FU/LV ROSWELL PARK: 204 [1-239] days; XELOX: 163 [1-275] days).
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Eligibility
Key inclusion criteria
- Histologically confirmed colon carcinoma, AJCC/UICC Stage III (Dukes stage C)
- Complete tumor resection; Patients operated with curative intent and with no
macroscopic or microscopic evidence for remaining tumor who can be randomized to
either treatment arm within 8 weeks after surgery. As this is an adjuvant trial
patients should never have had any evidence of metastatic disease (including presence
of tumor cells in the ascites).
- Have a life expectancy of at least 5 years
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
- Pregnant or lactating women
- Sexually active males and females (of childbearing potential) unwilling to practice
contraception during the study
- Previous cytotoxic chemotherapy, radiotherapy or immunotherapy, for the currently
treated colon cancer
- Patients who have not completely recovered from surgery
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
18/04/2003
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
21/04/2011
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Sample size
Target
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Accrual to date
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Final
1886
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Recruitment hospital [1]
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Royal Prince Alfred Hospital; Medical Oncology - Camperdown
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Recruitment hospital [2]
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Port Macquarie Base Hospital; Oncology - Port Macquarie
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Recruitment hospital [3]
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Southern Medical Day Care; Clinical Trials Unit - Wollongong
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Recruitment hospital [4]
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Queen Elizabeth Hospital; Medical Oncology - Woodville South
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Recruitment hospital [5]
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Box Hill Hospital; Oncology - Box Hill
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Recruitment hospital [6]
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Footscray Hospital - Footscray
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Recruitment hospital [7]
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St John of God Hospital; Medical Oncology - Perth
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Recruitment postcode(s) [1]
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2050 - Camperdown
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Recruitment postcode(s) [2]
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2444 - Port Macquarie
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2500 - Wollongong
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Recruitment postcode(s) [4]
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5011 - Woodville South
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Recruitment postcode(s) [5]
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3128 - Box Hill
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Recruitment postcode(s) [6]
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3011 - Footscray
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Recruitment postcode(s) [7]
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6008 - Perth
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Recruitment outside Australia
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Sutton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00069121
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Hoffmann-La Roche
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Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00069121
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