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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

Tracking Information
First Submitted Date  ICMJE September 15, 2003
First Posted Date  ICMJE September 18, 2003
Results First Submitted Date  ICMJE March 31, 2011
Results First Posted Date  ICMJE July 29, 2011
Last Update Posted Date August 22, 2013
Study Start Date  ICMJE January 2003
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 5, 2011)
  • 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. ]
    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.
  • 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. ]
    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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00069121 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 5, 2011)
  • 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. ]
    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.
  • 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. ]
    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.
  • 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. ]
    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.
  • 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. ]
    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.
  • 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 ]
    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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Xeloda (Capecitabine) Plus Oxaliplatin in Patients With Colon Cancer
Official Title  ICMJE 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.
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE
  • Drug: capecitabine [Xeloda]
    1000mg/m2 iv bid on days 1-15 of each 3 week cycle
  • Drug: Oxaliplatin
    As prescribed, in 3 week cycles
  • Drug: Oxaliplatin
    As prescribed, in 2 week cycles
  • Drug: Leucovorin
    As prescribed, in 2 week cycles.
  • Drug: 5 FU
    As prescribed, in 2 week cycles
Study Arms  ICMJE
  • Experimental: 1
    Interventions:
    • Drug: capecitabine [Xeloda]
    • Drug: Oxaliplatin
  • Active Comparator: 2
    Interventions:
    • Drug: Oxaliplatin
    • Drug: Leucovorin
    • Drug: 5 FU
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 5, 2011)
1886
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE April 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • adult patients >=18 years of age;
  • colon cancer;
  • complete tumor resection.

Exclusion Criteria:

  • prior treatment with cytotoxic chemotherapy, radiotherapy, or immunotherapy for the currently treated colon cancer.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Belgium,   Brazil,   Canada,   China,   Finland,   France,   Germany,   Greece,   Hong Kong,   Hungary,   Ireland,   Israel,   Italy,   Korea, Republic of,   Mexico,   New Zealand,   Panama,   Poland,   Portugal,   Russian Federation,   Singapore,   South Africa,   Spain,   Switzerland,   Taiwan,   Thailand,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00069121
Other Study ID Numbers  ICMJE NO16968
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor  ICMJE Hoffmann-La Roche
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP