An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer: Continued Avastin Plus Chemotherapy After First Progression in Clinical Practice

NCT ID: NCT02287597

Last Updated: 2018-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-11-13

Study Completion Date

2018-03-21

Brief Summary

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This local, non-interventional, cohort study of patients with metastatic colorectal cancer (mCRC) will prospectively collect data from standard clinical practice of second-line treatment with chemotherapy plus Avastin (bevacizumab). There will be no additional diagnostic or therapeutic procedures required by this study, apart from those performed in everyday clinical practice for second-line treatment of mCRC in Croatia.

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

* Written informed consent
* Age \>/=18 years
* Metastatic colorectal cancer (mCRC) previously treated with systemic treatment for advanced disease containing Avastin and chemotherapy; first-line Avastin received according to the Summary of Product Characteristics (SmPC)
* First line progression-free survival (PFS) \>6 months
* Eligible for second-line chemotherapy regimen
* Period between first progression and start of second line treatment with Avastin and chemotherapy \</=6 weeks

Exclusion Criteria

* Contraindications, warnings and precautions for use specified in the Avastin SmPC
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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Clinical Hospital Osijek; Dept For Oncology & Radiotherapy

Osijek, , Croatia

Site Status

Uni Hospital Split; Oncology & Radiotherapy

Split, , Croatia

Site Status

Clinical Hospital Centre Zagreb

Zagreb, , Croatia

Site Status

Uni Hospital For Tumours; Dept of Medical Oncology

Zagreb, , Croatia

Site Status

Countries

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Croatia

Other Identifiers

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ML29055

Identifier Type: -

Identifier Source: org_study_id

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