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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01609075
First received: May 29, 2012
Last updated: November 3, 2014
Last verified: November 2014
  Purpose

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


Condition
Colorectal Cancer

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Proportion of patients with Avastin treatment discontinuation due to either disease progression or Avastin-related adverse events [ Time Frame: approximately 15 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of patients with treatment discontinuation due to other causes [ Time Frame: approximately 15 months ] [ Designated as safety issue: No ]
  • Incidence of other causes for treatment discontinuation [ Time Frame: approximately 15 months ] [ Designated as safety issue: No ]
  • Second-line treatments initiated [ Time Frame: approximately 15 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 437
Study Start Date: June 2012
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01609075

  Hide Study Locations
Locations
Italy
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
Nocera Inferiore, Campania, Italy, 84014
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, 00157
Roma, Lazio, Italy, 00189
Roma, Lazio, Italy, 00185
Roma, Lazio, Italy, 00128
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
Como, Lombardia, Italy, 22100
Cremona, Lombardia, Italy, 26100
Lecco, Lombardia, Italy, 23900
Milano, Lombardia, Italy, 20099
Milano, Lombardia, Italy, 20142
Monza, Lombardia, Italy, 20052
Pavia, Lombardia, Italy, 27100
Saronno, Lombardia, Italy, 21047
Varese, Lombardia, Italy, 21100
Fano, Marche, Italy, 61032
Fermo, Marche, Italy, 63023
Macerata, Marche, Italy, 62100
Biella, Piemonte, Italy, 13900
Cuneo, Piemonte, Italy, 12100
Novara, Piemonte, Italy, 28100
Orbassano, Piemonte, Italy, 10043
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, 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
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01609075     History of Changes
Other Study ID Numbers: ML27907
Study First Received: May 29, 2012
Last Updated: November 3, 2014
Health Authority: Italy: Ministry of Health

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

ClinicalTrials.gov processed this record on November 23, 2014