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Trial record 2 of 436 for:    colon cancer AND Capecitabine

An Observational Study of Adjuvant Treatment With Capecitabine (Xeloda) in Combination With Oxaliplatin in Participants With Stage III Colon Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01442155
Recruitment Status : Completed
First Posted : September 28, 2011
Results First Posted : July 7, 2016
Last Update Posted : July 7, 2016
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Tracking Information
First Submitted Date September 26, 2011
First Posted Date September 28, 2011
Results First Submitted Date May 26, 2016
Results First Posted Date July 7, 2016
Last Update Posted Date July 7, 2016
Study Start Date October 2011
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 26, 2016)
Disease-Free Survival (Time to Event) [ Time Frame: Up to 3 years ]
Disease free survival was measured as the time from the date of randomization until the date of first event (recurrence of colon cancer, or death due to any cause).
Original Primary Outcome Measures
 (submitted: September 27, 2011)
Disease-free survival [ Time Frame: 3 years ]
Change History Complete list of historical versions of study NCT01442155 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: May 26, 2016)
Safety: Percentage of Participants With Adverse Events [ Time Frame: Up to 3 years ]
An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Original Secondary Outcome Measures
 (submitted: September 27, 2011)
Safety: Incidence of adverse events [ Time Frame: 3 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title An Observational Study of Adjuvant Treatment With Capecitabine (Xeloda) in Combination With Oxaliplatin in Participants With Stage III Colon Cancer
Official Title An Open Label Study of the Effect of Adjuvant Treatment With Capecitabine in Combination With Oxaliplatin on Disease-Free Survival in Patients With Stage III Colon Cancer
Brief Summary This observational study evaluates the efficacy and safety of capecitabine in combination with oxaliplatin in the adjuvant setting in participants with Stage III colon cancer. Data were collected from each participant for up to 36 months or until disease recurrence.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Participants with Stage III colon cancer
Condition Colorectal Cancer
Intervention
  • Drug: Capecitabine
    Administered according to the Summary of Product Characteristics.
    Other Name: Xeloda
  • Biological: Oxaliplatin
    Administered according to the Summary of Product Characteristics.
Study Groups/Cohorts Capecitabine + Oxaliplatin
Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care.
Interventions:
  • Drug: Capecitabine
  • Biological: Oxaliplatin
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 Completed
Actual Enrollment
 (submitted: May 26, 2016)
74
Original Estimated Enrollment
 (submitted: September 27, 2011)
77
Actual Study Completion Date April 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adult participants, >/= 18 years of age
  • Treatment in line with the currently approved indication in the Summary of Product Characteristics

Exclusion Criteria:

  • Contraindications according to the current Summary of Product Characteristics
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Slovakia
Removed Location Countries  
 
Administrative Information
NCT Number NCT01442155
Other Study ID Numbers ML25526
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Hoffmann-La Roche
Study Sponsor Hoffmann-La Roche
Collaborators Not Provided
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
PRS Account Hoffmann-La Roche
Verification Date May 2016