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

This study is currently recruiting participants.

Verified May 2013 by Hoffmann-La Roche

Sponsor:

Information provided by (Responsible Party):

Hoffmann-La Roche

ClinicalTrials.gov Identifier:

NCT01442155

First received: September 26, 2011

Last updated: May 7, 2013

Last verified: May 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

September 26, 2011

Last Updated Date

May 7, 2013

Start Date ^ICMJE

October 2011

Estimated Primary Completion Date

December 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Disease-free survival [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01442155 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Safety: Incidence of adverse events [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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 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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

Patients with Stage III colon cancer

Condition ^ICMJE

Colorectal Cancer

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Cohort

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

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2015

Estimated Primary Completion Date

December 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Please reference Study ID Number: ML25526 www.roche.com/about_roche/roche_worldwide.htm

888-662-6728 (U.S. Only)

genentechclinicaltrials@druginfo.com

Location Countries ^ICMJE

Slovakia

Administrative Information

NCT Number ^ICMJE

NCT01442155

Other Study ID Numbers ^ICMJE

ML25526

Has Data Monitoring Committee

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

Information Provided By

Hoffmann-La Roche

Verification Date

May 2013

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

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