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Trial record 68 of 5193 for:    colon cancer

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

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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

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Prospective
Condition Colorectal Cancer
Interventions Drug: Capecitabine
Biological: Oxaliplatin
Enrollment 74
Recruitment Details  
Pre-assignment Details Two participants were screening failures. 74 participants were assigned to the study and treated with study drug.
Arm/Group Title Capecitabine + Oxaliplatin
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Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care.

Capecitabine: Administered according to the Summary of Product Characteristics.

Oxaliplatin: Administered according to the Summary of Product Characteristics.

Period Title: Overall Study
Started 74
Completed 9
Not Completed 65
Reason Not Completed
Complete remission             35
Recurrence             26
Adverse Event             2
Lost to Follow-up             2
Arm/Group Title Capecitabine + Oxaliplatin
Hide Arm/Group Description

Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care.

Capecitabine: Administered according to the Summary of Product Characteristics.

Oxaliplatin: Administered according to the Summary of Product Characteristics.

Overall Number of Baseline Participants 74
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 74 participants
58.6  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 74 participants
Female
35
  47.3%
Male
39
  52.7%
1.Primary Outcome
Title Disease-Free Survival (Time to Event)
Hide Description 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).
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population included all participants treated with at least one dose of study drug. Here, number of participants analyzed is number evaluable for efficacy.
Arm/Group Title Capecitabine + Oxaliplatin
Hide Arm/Group Description:

Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care.

Capecitabine: Administered according to the Summary of Product Characteristics.

Oxaliplatin: Administered according to the Summary of Product Characteristics.

Overall Number of Participants Analyzed 67
Median (95% Confidence Interval)
Unit of Measure: months
25
(15.1 to 34.9)
2.Secondary Outcome
Title Safety: Percentage of Participants With Adverse Events
Hide Description 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.
Time Frame Up to 3 years
Hide Outcome Measure Data
Hide Analysis Population Description
Safety population included all participants treated with at least one dose of study drug.
Arm/Group Title Capecitabine + Oxaliplatin
Hide Arm/Group Description:

Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care.

Capecitabine: Administered according to the Summary of Product Characteristics.

Oxaliplatin: Administered according to the Summary of Product Characteristics.

Overall Number of Participants Analyzed 74
Measure Type: Number
Unit of Measure: percentage of participants
39.19
Time Frame Up to 3 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Capecitabine + Oxaliplatin
Hide Arm/Group Description

Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care.

Capecitabine: Administered according to the Summary of Product Characteristics.

Oxaliplatin: Administered according to the Summary of Product Characteristics.

All-Cause Mortality
Capecitabine + Oxaliplatin
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Capecitabine + Oxaliplatin
Affected / at Risk (%)
Total   1/74 (1.35%) 
Respiratory, thoracic and mediastinal disorders   
Respiratory failure  1  1/74 (1.35%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.1)
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Capecitabine + Oxaliplatin
Affected / at Risk (%)
Total   23/74 (31.08%) 
Blood and lymphatic system disorders   
Thrombocytopenia  1  8/74 (10.81%) 
Gastrointestinal disorders   
Diarrhea  1  8/74 (10.81%) 
Nausea  1  5/74 (6.76%) 
Nervous system disorders   
Neuropathy peripheral  1  7/74 (9.46%) 
Paresthesia  1  4/74 (5.41%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (18.1)
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 Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Medical Communications
Organization: Hoffmann-La Roche
Phone: 800 821-8590
EMail: genentech@druginfo.com
Layout table for additonal information
Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01442155     History of Changes
Other Study ID Numbers: ML25526
First Submitted: September 26, 2011
First Posted: September 28, 2011
Results First Submitted: May 26, 2016
Results First Posted: July 7, 2016
Last Update Posted: July 7, 2016