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Trial record 1 of 1 for:    NO16968
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A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer

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ClinicalTrials.gov Identifier: NCT00069121
Recruitment Status : Completed
First Posted : September 18, 2003
Results First Posted : July 29, 2011
Last Update Posted : August 22, 2013
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition: Colorectal Cancer
Interventions: Drug: capecitabine [Xeloda]
Drug: Oxaliplatin
Drug: Leucovorin
Drug: 5 FU

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
5-FU/LV

Given by one of two regimens.

  • 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
  • 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)
XELOX Capecitabine 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)

Participant Flow:   Overall Study
    5-FU/LV   XELOX
STARTED   942   944 
Received Treatment   926 [1]   938 [1] 
COMPLETED   640 [2]   668 [2] 
NOT COMPLETED   302   276 
Death                225                197 
Withdrawal by Subject                20                22 
Lost to Follow-up                57                57 
[1] Safety Population
[2] total includes Completed and Alive in follow-up



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
5-FU/LV

Given by one of two regimens.

  • 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
  • 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)
XELOX Capecitabine 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)
Total Total of all reporting groups

Baseline Measures
   5-FU/LV   XELOX   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 942   944   1886 
Age 
[Units: Years]
Mean (Standard Deviation) 		 60.5  (10.76)   59.8  (10.95)   60.2  (10.86) 
Gender 
[Units: Participants]
 		     
Female   442   431   873 
Male   500   513   1013 


  Outcome Measures

1.  Primary:   Disease-free Survival (DFS) [Number of Events]   [ Time Frame: 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. ]
  Show Outcome Measure 1

2.  Primary:   Disease-free Survival [Time to Event]   [ Time Frame: 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. ]
  Show Outcome Measure 2

3.  Secondary:   Relapse-free Survival (RFS) [Number of Events]   [ Time Frame: 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. ]
  Show Outcome Measure 3

4.  Secondary:   Relapse-free Survival (RFS) [Time to Event]   [ Time Frame: 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. ]
  Show Outcome Measure 4

5.  Secondary:   Overall Survival [Number of Events]   [ Time Frame: Time from randomization date to date of death/date last known to be alive. Median observation time for was approx 59 mos. ]
  Show Outcome Measure 5

6.  Secondary:   Overall Survival [Time to Event]   [ Time Frame: Time from randomization date to date of death/date last known to be alive. Median observation time for was approx 59 mos. ]
  Show Outcome Measure 6

7.  Secondary:   Number of Participants Assesed for Adverse Events   [ Time Frame: followed from Time of Very First Drug Intake and 28 day(s) after Very Last Drug Intake ]
  Show Outcome Measure 7


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Communications
Organization: Hoffman-LaRoche
phone: 800-821-8590


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):


Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT00069121     History of Changes
Obsolete Identifiers: NCT00080691
Other Study ID Numbers: NO16968
First Submitted: September 15, 2003
First Posted: September 18, 2003
Results First Submitted: March 31, 2011
Results First Posted: July 29, 2011
Last Update Posted: August 22, 2013