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

Use of Bevacizumab in the Treatment of Metastatic Colorectal Cancer (mCRC) in Italy: an Observational Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer

• Study Type: Observational
• Enrollment (Actual): 437

Contacts and Locations

Study Locations

• Italy
  • Abruzzo
    • L'aquila, Abruzzo, Italy, 67010
    • Teramo, Abruzzo, Italy, 64100
  • Basilicata
    • Rionero in Vulture, Basilicata, Italy, 85028
  • Calabria
    • Cosenza, Calabria, Italy, 87100
    • Lamezia Terme (CZ), Calabria, Italy, 88046
    • Reggio Calabria, Calabria, Italy, 89100
  • Campania
    • Benevento, Campania, Italy, 82100
    • Napoli, Campania, Italy, 80131
    • Napoli, Campania, Italy, 80100
    • Pagani ( Sa), Campania, Italy, 84016
  • Emilia-Romagna
    • Imola (BO), Emilia-Romagna, Italy, 40026
    • Modena, Emilia-Romagna, Italy, 41100
    • Parma, Emilia-Romagna, Italy, 43100
  • Friuli-Venezia Giulia
    • Pordenone, Friuli-Venezia Giulia, Italy, 33170
  • Lazio
    • Albano Laziale, Lazio, Italy, 00041
    • Roma, Lazio, Italy, 00189
    • Roma, Lazio, Italy, 00128
    • Roma, Lazio, Italy, 00157
    • Roma, Lazio, Italy, 00185
    • Sora, Lazio, Italy, 03039
    • Viterbo, Lazio, Italy, 01100
  • Liguria
    • Genova, Liguria, Italy, 16132
    • La Spezia, Liguria, Italy, 19100
    • Savona, Liguria, Italy
  • Lombardia
    • Bergamo, Lombardia, Italy, 24121
    • Brescia, Lombardia, Italy, 25124
    • Cremona, Lombardia, Italy, 26100
    • Lecco, Lombardia, Italy, 23900
    • Milano, Lombardia, Italy, 20142
    • Milano, Lombardia, Italy, 20099
    • Monza, Lombardia, Italy, 20900
    • Pavia, Lombardia, Italy, 27100
    • S. Fermo della Battaglia (CO), Lombardia, Italy, 22020
    • Saronno, Lombardia, Italy, 21047
    • Varese, Lombardia, Italy, 21100
  • Marche
    • Fano, Marche, Italy, 61032
    • Fermo, Marche, Italy, 63023
    • Macerata, Marche, Italy, 62100
  • Piemonte
    • Cuneo, Piemonte, Italy, 12100
    • Novara, Piemonte, Italy, 28100
    • Orbassano, Piemonte, Italy, 10043
    • Ponderano (BI), Piemonte, Italy, 13875
    • Torino, Piemonte, Italy, 10126
    • Torino, Piemonte, Italy, 10153
  • Puglia
    • Brindisi, Puglia, Italy, 72100
    • Castellana Grotte (BA), Puglia, Italy, 70013
    • Foggia, Puglia, Italy, 71100
    • Lecce, Puglia, Italy, 73100
    • San Giovanni Rotondo, Puglia, Italy, 71013
  • Sardegna
    • Cagliari, Sardegna, Italy, 09121
    • Sassari, Sardegna, Italy, 07100
  • Sicilia
    • Catania, Sicilia, Italy, 95123
    • Cefalu, Sicilia, Italy, 90015
    • Messina, Sicilia, Italy, 98125
    • Messina, Sicilia, Italy, 98158
    • Palermo, Sicilia, Italy, 90100
    • Taormina, Sicilia, Italy, 98030
    • Vimercate, Sicilia, Italy, 20059
  • Toscana
    • Grosseto, Toscana, Italy, 58100
    • Lido Di Camaiore, Toscana, Italy, 55043
    • Livorno, Toscana, Italy, 57100
    • Pontedera, Toscana, Italy, 56025
    • Siena, Toscana, Italy, 53100
  • Umbria
    • Perugia, Umbria, Italy, 06156
  • Veneto
    • Cona (Ferrara), Veneto, Italy, 44124
    • Este, Veneto, Italy, 35042
    • Este (PD), Veneto, Italy, 35042
    • Mirano, Veneto, Italy, 30035
    • Montecchio Maggiore, Veneto, Italy, 36075
    • Padova, Veneto, Italy, 35128
    • Rovigo, Veneto, Italy, 45100
    • Treviso, Veneto, Italy, 31100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with metastatic colorectal cancer having initiated first-line treatment with fluoropyrimidine-based chemotherapy and Avastin

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with Avastin treatment discontinuation due to either disease progression or Avastin-related adverse events	approximately 15 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients with treatment discontinuation due to other causes	approximately 15 months
Incidence of other causes for treatment discontinuation	approximately 15 months
Second-line treatments initiated	approximately 15 months
Progression-free survival (patients with treatment discontinuation due to disease progression or Avastin-related toxicity as compared to patients with treatment discontinuation due to other causes)	approximately 15 months

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): June 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: May 29, 2012
• First Submitted That Met QC Criteria: May 29, 2012
• First Posted (Estimate): May 31, 2012

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: ML27907