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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01442155
First received: September 26, 2011
Last updated: May 26, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention
Colorectal Cancer
Drug: Capecitabine
Biological: Oxaliplatin

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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Disease-Free Survival (Time to Event) [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    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:
  • Safety: Percentage of Participants With Adverse Events [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    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.


Enrollment: 74
Study Start Date: October 2011
Study Completion Date: April 2015
Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Capecitabine + Oxaliplatin
Participants with stage lll colon cancer, who were starting adjuvant chemotherapy with capecitabine in combination with oxaliplatin according to standard of care.
Drug: Capecitabine
Administered according to the Summary of Product Characteristics.
Other Name: Xeloda
Biological: Oxaliplatin
Administered according to the Summary of Product Characteristics.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Participants with Stage III colon cancer
Criteria

Inclusion Criteria:

  • Adult participants, >/= 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 ClinicalTrials.gov identifier: NCT01442155

Locations
Slovakia
Banska Bystrica, Slovakia, 975 17
Bratislava, Slovakia, 812 50
Bratislava, Slovakia, 833 10
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
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01442155     History of Changes
Other Study ID Numbers: ML25526 
Study First Received: September 26, 2011
Results First Received: May 26, 2016
Last Updated: May 26, 2016
Health Authority: Slovakia: State Institute for Drug Control

Keywords provided by Hoffmann-La Roche:
Colorectal cancer
Adjuvant setting
Capecitabine
Oxaliplatin

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Capecitabine
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents

ClinicalTrials.gov processed this record on December 09, 2016