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:
Hoffmann-La Roche
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
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Purpose
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.
| 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 ]
| Estimated Enrollment: | 77 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | December 2015 |
| Estimated Primary Completion Date: | December 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Cohort |
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01442155
Contacts
| Contact: Please reference Study ID Number: ML25526 www.roche.com/about_roche/roche_worldwide.htm | 888-662-6728 (U.S. Only) | genentechclinicaltrials@druginfo.com |
Locations
| Slovakia | |
| Recruiting | |
| Banska Bystrica, Slovakia, 975 17 | |
| Recruiting | |
| Bratislava, Slovakia, 833 10 | |
| Recruiting | |
| Bratislava, Slovakia, 812 50 | |
| Recruiting | |
| Kosice, Slovakia, 04191 | |
| Recruiting | |
| Martin, Slovakia, 036 59 | |
| Recruiting | |
| Nitra, Slovakia, 950 01 | |
| Recruiting | |
| Poprad, Slovakia, 058 01 | |
| Recruiting | |
| Presov, Slovakia, 081 81 | |
| Recruiting | |
| 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: | May 7, 2013 |
| Health Authority: | Slovakia: State Institute for the Control of Drugs |
Additional relevant MeSH terms:
|
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases |
Intestinal Diseases Rectal Diseases Oxaliplatin Capecitabine Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antimetabolites, Antineoplastic Antimetabolites Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on May 22, 2013