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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01442155
First received: September 26, 2011
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

This observational study will evaluate the efficacy and safety of Xeloda (capeci tabine) 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.


Condition
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

Resource links provided by NLM:


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
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)

  Eligibility

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

Criteria

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 ClinicalTrials.gov identifier: NCT01442155

Locations
Slovakia
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
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01442155     History of Changes
Other Study ID Numbers: ML25526
Study First Received: September 26, 2011
Last Updated: November 3, 2014
Health Authority: Slovakia: State Institute for the Control of Drugs

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

ClinicalTrials.gov processed this record on November 27, 2014