An Observational Study of Xeloda (Capecitabine) in Patients With Metastatic Colorectal Cancer (AXIOM)

NCT ID: NCT01697462

Last Updated: 2016-01-26

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

258 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-31

Study Completion Date

2012-12-31

Brief Summary

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This prospective observational study will evaluate the safety and efficacy of Xeloda (capecitabine) administered in monotherapy in patients with metastatic colorectal cancer. Patients will be followed until disease progression or unacceptable toxicity occurs.

Detailed Description

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Conditions

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Colorectal Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Adult patients, \>/= 18 years of age
* Metastatic colorectal cancer
* Receiving Xeloda according to registered indication

Exclusion Criteria

* Patients who are not eligible for Xeloda treatment according to the Summary of Product Characteristics
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Belgrade, , Serbia

Site Status

Belgrade, , Serbia

Site Status

Kamenitz, , Serbia

Site Status

Kragujevac, , Serbia

Site Status

Niš, , Serbia

Site Status

Countries

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Serbia

Other Identifiers

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ML22585

Identifier Type: -

Identifier Source: org_study_id

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