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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: September 26, 2011
Last updated: April 2, 2016
Last verified: April 2016

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.

Colorectal Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Further study details as provided by Hoffmann-La Roche:

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

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

Enrollment: 75
Study Start Date: October 2011
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with Stage III colon cancer

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01442155

Banska Bystrica, Slovakia, 975 17
Bratislava, Slovakia, 833 10
Bratislava, Slovakia, 812 50
Kosice, Slovakia, 04001
Martin, Slovakia, 036 59
Nitra, Slovakia, 950 01
Poprad, Slovakia, 058 01
Presov, Slovakia, 081 81
Ruzomberok, Slovakia, 03426
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT01442155     History of Changes
Other Study ID Numbers: ML25526 
Study First Received: September 26, 2011
Last Updated: April 2, 2016
Health Authority: Slovakia: State Institute for the Control of Drugs processed this record on May 25, 2016