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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01609075
Recruitment Status : Completed
First Posted : May 31, 2012
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
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.

Condition or disease
Colorectal Cancer

Study Type : Observational
Actual Enrollment : 437 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Use of Bevacizumab in the Treatment of Metastatic Colorectal Cancer (mCRC) in Italy: an Observational Cohort Study
Study Start Date : June 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Bevacizumab
U.S. FDA Resources


Primary Outcome Measures :
  1. Proportion of patients with Avastin treatment discontinuation due to either disease progression or Avastin-related adverse events [ Time Frame: approximately 15 months ]

Secondary Outcome Measures :
  1. Proportion of patients with treatment discontinuation due to other causes [ Time Frame: approximately 15 months ]
  2. Incidence of other causes for treatment discontinuation [ Time Frame: approximately 15 months ]
  3. Second-line treatments initiated [ Time Frame: approximately 15 months ]
  4. 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) [ Time Frame: approximately 15 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with metastatic colorectal cancer having initiated first-line treatment with fluoropyrimidine-based chemotherapy and Avastin

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01609075

  Hide Study Locations
L'aquila, Abruzzo, Italy, 67010
Teramo, Abruzzo, Italy, 64100
Rionero in Vulture, Basilicata, Italy, 85028
Cosenza, Calabria, Italy, 87100
Lamezia Terme (CZ), Calabria, Italy, 88046
Reggio Calabria, Calabria, Italy, 89100
Benevento, Campania, Italy, 82100
Napoli, Campania, Italy, 80100
Napoli, Campania, Italy, 80131
Pagani ( Sa), Campania, Italy, 84016
Imola (BO), Emilia-Romagna, Italy, 40026
Modena, Emilia-Romagna, Italy, 41100
Parma, Emilia-Romagna, Italy, 43100
Pordenone, Friuli-Venezia Giulia, Italy, 33170
Albano Laziale, Lazio, Italy, 00041
Roma, Lazio, Italy, 00128
Roma, Lazio, Italy, 00157
Roma, Lazio, Italy, 00185
Roma, Lazio, Italy, 00189
Sora, Lazio, Italy, 03039
Viterbo, Lazio, Italy, 01100
Genova, Liguria, Italy, 16132
La Spezia, Liguria, Italy, 19100
Savona, Liguria, Italy
Bergamo, Lombardia, Italy, 24121
Brescia, Lombardia, Italy, 25124
Cremona, Lombardia, Italy, 26100
Lecco, Lombardia, Italy, 23900
Milano, Lombardia, Italy, 20099
Milano, Lombardia, Italy, 20142
Monza, Lombardia, Italy, 20900
Pavia, Lombardia, Italy, 27100
S. Fermo della Battaglia (CO), Lombardia, Italy, 22020
Saronno, Lombardia, Italy, 21047
Varese, Lombardia, Italy, 21100
Fano, Marche, Italy, 61032
Fermo, Marche, Italy, 63023
Macerata, Marche, Italy, 62100
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
Brindisi, Puglia, Italy, 72100
Castellana Grotte (BA), Puglia, Italy, 70013
Foggia, Puglia, Italy, 71100
Lecce, Puglia, Italy, 73100
San Giovanni Rotondo, Puglia, Italy, 71013
Cagliari, Sardegna, Italy, 09121
Sassari, Sardegna, Italy, 07100
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
Grosseto, Toscana, Italy, 58100
Lido Di Camaiore, Toscana, Italy, 55043
Livorno, Toscana, Italy, 57100
Pontedera, Toscana, Italy, 56025
Siena, Toscana, Italy, 53100
Perugia, Umbria, Italy, 06156
Cona (Ferrara), Veneto, Italy, 44124
Este (PD), Veneto, Italy, 35042
Este, Veneto, Italy, 35042
Mirano, Veneto, Italy, 30035
Montecchio Maggiore, Veneto, Italy, 36075
Padova, Veneto, Italy, 35128
Rovigo, Veneto, Italy, 45100
Treviso, Veneto, Italy, 31100
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT01609075     History of Changes
Other Study ID Numbers: ML27907
First Posted: May 31, 2012    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents