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A Study of Xeloda (Capecitabine) as Adjuvant Monotherapy in Patients With Colon Cancer.

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ClinicalTrials.gov Identifier: NCT00502671
Recruitment Status : Completed
First Posted : July 18, 2007
Results First Posted : September 3, 2015
Last Update Posted : September 3, 2015
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date  ICMJE July 17, 2007
First Posted Date  ICMJE July 18, 2007
Results First Submitted Date  ICMJE August 6, 2015
Results First Posted Date  ICMJE September 3, 2015
Last Update Posted Date September 3, 2015
Study Start Date  ICMJE July 2007
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2015)
Percentage of Participants With an Adverse Event (AE), Serious AE, or Death Due to an AE [ Time Frame: Up to 25 weeks (from Baseline to the end of safety follow-up) ]
The postmarketing safety profile of capecitabine was evaluated by collection of AEs, clinical laboratory data, vital signs, and other findings from physical examination. Abnormalities in these findings were captured as AEs, defined as any untoward medical occurrence in a study participant regardless of the suspected cause. Serious AEs were those which, at any dose, met one or more of the following criteria: resulted in fatality, were life-threatening, necessitated new or prolonged existing hospitalization, produced persistent or significant disability, resulted in congenital anomaly or birth defect, were considered medically significant, or required intervention to prevent any of the aforementioned outcomes. Those specific serious AEs which resulted in fatality were also reported separately. The percentage of participants with an AE, serious AE, or AE resulting in death was calculated as [number of participants with event divided by number analyzed] multiplied by 100.
Original Primary Outcome Measures  ICMJE
 (submitted: July 17, 2007)
Serious adverse events, AEs, laboratory abnormalities.
Change History Complete list of historical versions of study NCT00502671 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2015)
Percentage of Participants With Early Withdrawal or Discontinuation Due to an AE [ Time Frame: Up to 25 weeks (from Baseline to the end of safety follow-up) ]
The postmarketing safety profile of capecitabine was evaluated by collection of AEs, clinical laboratory data, vital signs, and other findings from physical examination. Abnormalities in these findings were captured as AEs, defined as any untoward medical occurrence in a study participant regardless of the suspected cause. The percentage of participants with early withdrawal or treatment discontinuation due to an AE was calculated as [number of participants with event divided by number analyzed] multiplied by 100.
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) as Adjuvant Monotherapy in Patients With Colon Cancer.
Official Title  ICMJE An Open Label Study to Evaluate the Safety of Xeloda as Adjuvant Monotherapy in Patients Who Have Undergone Surgery for Colon Cancer, Dukes Stage C.
Brief Summary This single arm study will evaluate the safety profile of Xeloda as monotherapy for adjuvant treatment of colon cancer. All patients will receive Xeloda 1250mg/m2 p.o. twice daily as intermittent treatment (3 week cycles consisting of 2 weeks of treatment followed by 1 week without treatment). The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Colorectal Cancer
Intervention  ICMJE Drug: capecitabine [Xeloda]
1250mg/m2 po bid on days 1-14 of each 3 week cycle
Study Arms  ICMJE Experimental: 1
Intervention: Drug: capecitabine [Xeloda]
Publications * Not Provided

*   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: April 15, 2013)
228
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE March 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • adult patients, >=18 years of age;
  • colon cancer (Dukes stage C);
  • surgery, with no evidence of remaining tumor;
  • ECOG performance status of <=1.

Exclusion Criteria:

  • previous therapy for currently treated colon cancer;
  • any evidence of metastatic disease;
  • history of other malignancy within last 5 years;
  • clinically significant cardiac disease.
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 Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00502671
Other Study ID Numbers  ICMJE ML20592
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 2015

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