An Observational Study of Avastin (Bevacizumab) in Combination With Xeloda (Capecitabine) And Oxaliplatin in Patients With Colorectal Cancer

NCT ID: NCT01399190

Last Updated: 2016-09-28

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

68 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2014-02-28

Brief Summary

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This prospective observational study will evaluate the efficacy and safety of bevacizumab in combination with capecitabine and oxaliplatin as first-line treatment in participants with colorectal cancer. Data will be collected from each participant until disease progression occurs (for up to 30 months).

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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Bevacizumab

Participants will receive bevacizumab in combination with capecitabine and oxaliplatin.

Bevacizumab

Intervention Type BIOLOGICAL

Bevacizumab administered according to prescribing information and normal clinical practice.

Capecitabine

Intervention Type BIOLOGICAL

Capecitabine administered according to prescribing information and normal clinical practice.

Oxaliplatin

Intervention Type DRUG

Capecitabine administered according to prescribing information and normal clinical practice.

Interventions

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Bevacizumab

Bevacizumab administered according to prescribing information and normal clinical practice.

Intervention Type BIOLOGICAL

Capecitabine

Capecitabine administered according to prescribing information and normal clinical practice.

Intervention Type BIOLOGICAL

Oxaliplatin

Capecitabine administered according to prescribing information and normal clinical practice.

Intervention Type DRUG

Other Intervention Names

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Avastin® Xeloda® Eloxatin™

Eligibility Criteria

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Inclusion Criteria

* Adult patients, \>/= 18 years of age
* Metastatic colorectal cancer
* Treatment in accordance with current Summary of Product Characteristics and local guidelines

Exclusion Criteria

* Contraindications according to current Summary of Product Characteristics and local guidelines
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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Banská Bystrica, , Slovakia

Site Status

Bratislava, , Slovakia

Site Status

Bratislava, , Slovakia

Site Status

Košice, , Slovakia

Site Status

Martin, , Slovakia

Site Status

Nitra, , Slovakia

Site Status

Poprad, , Slovakia

Site Status

Prešov, , Slovakia

Site Status

Ružomberok, , Slovakia

Site Status

Countries

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Slovakia

Other Identifiers

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ML25523

Identifier Type: -

Identifier Source: org_study_id

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