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NCT01442155 Clinical Trial

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

Colorectal Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01442155
Other study ID # ML25526
Secondary ID
Status Completed
Phase N/A
First received September 26, 2011
Last updated April 2, 2016
Start date October 2011
Est. completion date April 2015

Study information
Verified date April 2016
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority Slovakia: State Institute for the Control of Drugs
Study type Observational

Clinical Trial Summary

This observational study will evaluate the efficacy and safety of Xeloda (capecitabine) in combination with oxaliplatin in the adjuvant setting in patients with Stage III colon cancer.

Data will be collected from each patient for up to 36 months or until disease recurrence.

Recruitment information / eligibility
Status Completed
Enrollment 75
Est. completion date April 2015
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Adult patients, >/= 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Slovakia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Disease-free survival 3 years No
Secondary Safety: Incidence of adverse events 3 years No
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