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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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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/study/NCT00069121
Trial related presentations / publications
Gallois C, Shi Q, Meyers JP, Iveson T, Alberts SR, de Gramont A, Sobrero AF, Haller DG, Oki E, Shields AF, Goldberg RM, Kerr R, Lonardi S, Yothers G, Kelly C, Boukovinas I, Labianca R, Sinicrope FA, Souglakos I, Yoshino T, Meyerhardt JA, Andre T, Papamichael D, Taieb J. Prognostic Impact of Early Treatment and Oxaliplatin Discontinuation in Patients With Stage III Colon Cancer: An ACCENT/IDEA Pooled Analysis of 11 Adjuvant Trials. J Clin Oncol. 2023 Feb 1;41(4):803-815. doi: 10.1200/JCO.21.02726. Epub 2022 Oct 28.
Schmoll HJ, Tabernero J, Maroun J, de Braud F, Price T, Van Cutsem E, Hill M, Hoersch S, Rittweger K, Haller DG. Capecitabine Plus Oxaliplatin Compared With Fluorouracil/Folinic Acid As Adjuvant Therapy for Stage III Colon Cancer: Final Results of the NO16968 Randomized Controlled Phase III Trial. J Clin Oncol. 2015 Nov 10;33(32):3733-40. doi: 10.1200/JCO.2015.60.9107. Epub 2015 Aug 31.
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

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00069121