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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/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
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)
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
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.
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]
Timepoint [1] 0 0
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).
Primary outcome [2] 0 0
Disease-Free Survival (DFS) [Time to Event]
Timepoint [2] 0 0
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).
Secondary outcome [1] 0 0
Relapse-Free Survival (RFS) [Number of Events]
Timepoint [1] 0 0
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).
Secondary outcome [2] 0 0
Relapse-Free Survival (RFS) [Time to Event]
Timepoint [2] 0 0
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).
Secondary outcome [3] 0 0
Overall Survival [Number of Events]
Timepoint [3] 0 0
Time from randomization date to date of death/date last known to be alive. Median observation time was 83 months (range: 0-95 months).
Secondary outcome [4] 0 0
Overall Survival [Time to Event]
Timepoint [4] 0 0
Time from randomization date to date of death/date last known to be alive. Median observation time was 83 months (range: 0-95 months).
Secondary outcome [5] 0 0
Number of Participants With at Least One Adverse Event by Most Severe Intensity
Timepoint [5] 0 0
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).

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

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
18/04/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
21/04/2011
Sample size
Target
Accrual to date
Final
1886
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital; Medical Oncology - Camperdown
Recruitment hospital [2] 0 0
Port Macquarie Base Hospital; Oncology - Port Macquarie
Recruitment hospital [3] 0 0
Southern Medical Day Care; Clinical Trials Unit - Wollongong
Recruitment hospital [4] 0 0
Queen Elizabeth Hospital; Medical Oncology - Woodville South
Recruitment hospital [5] 0 0
Box Hill Hospital; Oncology - Box Hill
Recruitment hospital [6] 0 0
Footscray Hospital - Footscray
Recruitment hospital [7] 0 0
St John of God Hospital; Medical Oncology - Perth
Recruitment postcode(s) [1] 0 0
2050 - Camperdown
Recruitment postcode(s) [2] 0 0
2444 - Port Macquarie
Recruitment postcode(s) [3] 0 0
2500 - Wollongong
Recruitment postcode(s) [4] 0 0
5011 - Woodville South
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
3011 - Footscray
Recruitment postcode(s) [7] 0 0
6008 - Perth
Recruitment outside Australia
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Alabama
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California
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Bury St Edmunds
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Cambridge
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Derby
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Glasgow
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Northwood
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Salisbury
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Southampton
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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
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/NCT00069121