Clinical trial NCT01609075: An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer in Italy (BEWARE)
Official title: Use of Bevacizumab in the Treatment of Metastatic Colorectal Cancer (mCRC) in Italy: an Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Colorectal Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2012-05-31
Enrollment: 437
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with metastatic colorectal cancer having initiated first-line treatment with fluoropyrimidine-based chemotherapy and Avastin

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.


Eligibility 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

Primary outcomes:
measure: Proportion of patients with Avastin treatment discontinuation due to either disease progression or Avastin-related adverse events
timeFrame: approximately 15 months
Secondary outcomes:
measure: Proportion of patients with treatment discontinuation due to other causes
timeFrame: approximately 15 months
measure: Incidence of other causes for treatment discontinuation
timeFrame: approximately 15 months
measure: Second-line treatments initiated
timeFrame: approximately 15 months
measure: 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)
timeFrame: approximately 15 months
Other outcomes:
Locations:
city: L'aquila
country: Italy
state: Abruzzo
city: Teramo
country: Italy
state: Abruzzo
city: Rionero in Vulture
country: Italy
state: Basilicata
city: Cosenza
country: Italy
state: Calabria
city: Lamezia Terme (CZ)
country: Italy
state: Calabria
city: Reggio Calabria
country: Italy
state: Calabria
city: Benevento
country: Italy
state: Campania
city: Napoli
country: Italy
state: Campania
city: Napoli
country: Italy
state: Campania
city: Pagani ( Sa)
country: Italy
state: Campania
city: Imola (BO)
country: Italy
state: Emilia-Romagna
city: Modena
country: Italy
state: Emilia-Romagna
city: Parma
country: Italy
state: Emilia-Romagna
city: Pordenone
country: Italy
state: Friuli-Venezia Giulia
city: Albano Laziale
country: Italy
state: Lazio
city: Roma
country: Italy
state: Lazio
city: Roma
country: Italy
state: Lazio
city: Roma
country: Italy
state: Lazio
city: Roma
country: Italy
state: Lazio
city: Sora
country: Italy
state: Lazio
city: Viterbo
country: Italy
state: Lazio
city: Genova
country: Italy
state: Liguria
city: La Spezia
country: Italy
state: Liguria
city: Savona
country: Italy
state: Liguria
city: Bergamo
country: Italy
state: Lombardia
city: Brescia
country: Italy
state: Lombardia
city: Cremona
country: Italy
state: Lombardia
city: Lecco
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Milano
country: Italy
state: Lombardia
city: Monza
country: Italy
state: Lombardia
city: Pavia
country: Italy
state: Lombardia
city: S. Fermo della Battaglia (CO)
country: Italy
state: Lombardia
city: Saronno
country: Italy
state: Lombardia
city: Varese
country: Italy
state: Lombardia
city: Fano
country: Italy
state: Marche
city: Fermo
country: Italy
state: Marche
city: Macerata
country: Italy
state: Marche
city: Cuneo
country: Italy
state: Piemonte
city: Novara
country: Italy
state: Piemonte
city: Orbassano
country: Italy
state: Piemonte
city: Ponderano (BI)
country: Italy
state: Piemonte
city: Torino
country: Italy
state: Piemonte
city: Torino
country: Italy
state: Piemonte
city: Brindisi
country: Italy
state: Puglia
city: Castellana Grotte (BA)
country: Italy
state: Puglia
city: Foggia
country: Italy
state: Puglia
city: Lecce
country: Italy
state: Puglia
city: San Giovanni Rotondo
country: Italy
state: Puglia
city: Cagliari
country: Italy
state: Sardegna
city: Sassari
country: Italy
state: Sardegna
city: Catania
country: Italy
state: Sicilia
city: Cefalu
country: Italy
state: Sicilia
city: Messina
country: Italy
state: Sicilia
city: Messina
country: Italy
state: Sicilia
city: Palermo
country: Italy
state: Sicilia
city: Taormina
country: Italy
state: Sicilia
city: Vimercate
country: Italy
state: Sicilia
city: Grosseto
country: Italy
state: Toscana
city: Lido Di Camaiore
country: Italy
state: Toscana
city: Livorno
country: Italy
state: Toscana
city: Pontedera
country: Italy
state: Toscana
city: Siena
country: Italy
state: Toscana
city: Perugia
country: Italy
state: Umbria
city: Cona (Ferrara)
country: Italy
state: Veneto
city: Este (PD)
country: Italy
state: Veneto
city: Este
country: Italy
state: Veneto
city: Mirano
country: Italy
state: Veneto
city: Montecchio Maggiore
country: Italy
state: Veneto
city: Padova
country: Italy
state: Veneto
city: Rovigo
country: Italy
state: Veneto
city: Treviso
country: Italy
state: Veneto
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.