An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer in Italy (BEWARE)

NCT ID: NCT01609075

Last Updated: 2016-11-02

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

437 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-06-30

Brief Summary

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This observational, multicenter, retrospective/prospective study will evaluate the use of Avastin (bevacizumab) in clinical practice in patients with metastatic colorectal cancer. Patients having initiated first-line treatment with a fluoropyrimidine-based chemotherapy and Avastin will be followed for up to 15 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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Cohort

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Adult patients, \>/= 18 years of age
* Metastatic colorectal cancer
* Having initiated first-line treatment with fluoropyrimidine-based chemotherapy plus Avastin between 1. September 2011 and 29. February 2012
* Availability of test fro K-RAS genotyping

Exclusion Criteria

* Participation in a clinical trial during treatment with Avastin
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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L’Aquila, Abruzzo, Italy

Site Status

Teramo, Abruzzo, Italy

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Brindisi, Apulia, Italy

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Castellana Grotte (BA), Apulia, Italy

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Foggia, Apulia, Italy

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Lecce, Apulia, Italy

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San Giovanni Rotondo, Apulia, Italy

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Rionero in Vulture, Basilicate, Italy

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Cosenza, Calabria, Italy

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Lamezia Terme (CZ), Calabria, Italy

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Reggio Calabria, Calabria, Italy

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Benevento, Campania, Italy

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Napoli, Campania, Italy

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Napoli, Campania, Italy

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Pagani ( Sa), Campania, Italy

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Imola (BO), Emilia-Romagna, Italy

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Modena, Emilia-Romagna, Italy

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Parma, Emilia-Romagna, Italy

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Pordenone, Friuli Venezia Giulia, Italy

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Albano Laziale, Lazio, Italy

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Rome, Lazio, Italy

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Rome, Lazio, Italy

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Rome, Lazio, Italy

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Rome, Lazio, Italy

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Sora, Lazio, Italy

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Viterbo, Lazio, Italy

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Genoa, Liguria, Italy

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La Spezia, Liguria, Italy

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Savona, Liguria, Italy

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Bergamo, Lombardy, Italy

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Brescia, Lombardy, Italy

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Cremona, Lombardy, Italy

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Lecco, Lombardy, Italy

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Milan, Lombardy, Italy

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Milan, Lombardy, Italy

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Monza, Lombardy, Italy

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Pavia, Lombardy, Italy

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S. Fermo Della Battaglia (CO), Lombardy, Italy

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Saronno, Lombardy, Italy

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Varese, Lombardy, Italy

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Cuneo, Piedmont, Italy

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Novara, Piedmont, Italy

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Orbassano, Piedmont, Italy

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Ponderano (BI), Piedmont, Italy

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Turin, Piedmont, Italy

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Turin, Piedmont, Italy

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Cagliari, Sardinia, Italy

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Sassari, Sardinia, Italy

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Catania, Sicily, Italy

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Cefalù, Sicily, Italy

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Messina, Sicily, Italy

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Messina, Sicily, Italy

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Palermo, Sicily, Italy

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Taormina, Sicily, Italy

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Vimercate, Sicily, Italy

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Fano, The Marches, Italy

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Fermo, The Marches, Italy

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Macerata, The Marches, Italy

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Grosseto, Tuscany, Italy

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Lido di Camaiore, Tuscany, Italy

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Livorno, Tuscany, Italy

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Pontedera, Tuscany, Italy

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Siena, Tuscany, Italy

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Perugia, Umbria, Italy

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Cona (Ferrara), Veneto, Italy

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Este, Veneto, Italy

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Este (PD), Veneto, Italy

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Mirano, Veneto, Italy

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Montecchio Maggiore, Veneto, Italy

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Padua, Veneto, Italy

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Rovigo, Veneto, Italy

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Treviso, Veneto, Italy

Site Status

Countries

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Italy

References

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Lonardi S, Nasti G, Fagnani D, Gemma D, Ciuffreda L, Granetto C, Lucchesi S, Ballestrero A, Biglietto M, Proserpio I, Bergamo F, Proietti E, Tonini G. Discontinuation of first-line bevacizumab in metastatic colorectal cancer: the BEAWARE Italian Observational Study. Tumori. 2019 Jun;105(3):243-252. doi: 10.1177/0300891619834126. Epub 2019 Mar 11.

Reference Type DERIVED
PMID: 30857495 (View on PubMed)

Other Identifiers

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ML27907

Identifier Type: -

Identifier Source: org_study_id