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

Completed

• Conditions: Colorectal Cancer
• Interventions: Drug: Capecitabine; Biological: Oxaliplatin

• Registration Number: NCT01442155
• Lead Sponsor: Hoffmann-La Roche

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 available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2011-09-26
• Study First Submitted QC: 2011-09-27
• Study First Posted: 2011-09-28
• Study Start: 2011-10
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2016-05
• Results First Submitted: 2016-05-26
• Results First Submitted QC: 2016-05-26
• Last Update Submitted: 2016-05-26
• Results First Posted: 2016-07-07
• Last Update Posted: 2016-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

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

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Exclusion Criteria

• Contraindications according to the current Summary of Product Characteristics

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Capecitabine + Oxaliplatin	Oxaliplatin	Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care.
Capecitabine + Oxaliplatin	Capecitabine	Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care.

Primary Outcome Measures

Name	Time	Method
Disease-Free Survival (Time to Event)	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).

Secondary Outcome Measures

Name	Time	Method
Safety: Percentage of Participants With Adverse Events	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.