Colorectal CancerNCT01609075
An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer in Italy (BEWARE)
An observational study of Colorectal Cancer, run by Hoffmann-La Roche at 72 sites in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- How many people
- 437 participants
- Where
- 72 sitesItaly
- Study dates
- Jun 2012to Jun 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with metastatic colorectal cancer having initiated first-line treatment with fluoropyrimidine-based chemotherapy and Avastin
Who may be able to join
- 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
Who cannot join
- Participation in a clinical trial during treatment with Avastin
Trial locations and contacts
72 sites in 1 country.
72 sites in 1 country
Italy72 sites
Study site
Albano Laziale, Lazio, 00041
Study site
Benevento, Campania, 82100
Study site
Bergamo, Lombardy, 24121
Study site
Brescia, Lombardy, 25124
Study site
Brindisi, Apulia, 72100
Study site
Cagliari, Sardinia, 09121
Study site
Castellana Grotte (BA), Apulia, 70013
Study site
Catania, Sicily, 95123
Study site
Cefalù, Sicily, 90015
Study site
Cona (Ferrara), Veneto, 44124
Study site
Cosenza, Calabria, 87100
Study site
Cremona, Lombardy, 26100
Study site
Cuneo, Piedmont, 12100
Study site
Este, Veneto, 35042
Study site
Este (PD), Veneto, 35042
Study site
Fano, The Marches, 61032
Study site
Fermo, The Marches, 63023
Study site
Foggia, Apulia, 71100
Study site
Genoa, Liguria, 16132
Study site
Grosseto, Tuscany, 58100
Study site
Imola (BO), Emilia-Romagna, 40026
Study site
L’Aquila, Abruzzo, 67010
Study site
La Spezia, Liguria, 19100
Study site
Lamezia Terme (CZ), Calabria, 88046
Study site
Lecce, Apulia, 73100
Study site
Lecco, Lombardy, 23900
Study site
Lido di Camaiore, Tuscany, 55043
Study site
Livorno, Tuscany, 57100
Study site
Messina, Sicily, 98125
Study site
Messina, Sicily, 98158
Study site
Milan, Lombardy, 20099
Study site
Milan, Lombardy, 20142
Study site
Mirano, Veneto, 30035
Study site
Modena, Emilia-Romagna, 41100
Study site
Montecchio Maggiore, Veneto, 36075
Study site
Monza, Lombardy, 20900
Study site
Naples, Campania, 80100
Study site
Naples, Campania, 80131
Study site
Novara, Piedmont, 28100
Study site
Orbassano, Piedmont, 10043
Study site
Padova, Veneto, 35128
Study site
Pagani ( Sa), Campania, 84016
Study site
Palermo, Sicily, 90100
Study site
Parma, Emilia-Romagna, 43100
Study site
Pavia, Lombardy, 27100
Study site
Perugia, Umbria, 06156
Study site
Ponderano (BI), Piedmont, 13875
Study site
Pontedera, Tuscany, 56025
Study site
Pordenone, Friuli Venezia Giulia, 33170
Study site
Province of Macerata, The Marches, 62100
Study site
Reggio Calabria, Calabria, 89100
Study site
Rionero in Vulture, Basilicate, 85028
Study site
Rome, Lazio, 00128
Study site
Rome, Lazio, 00157
Study site
Rome, Lazio, 00185
Study site
Rome, Lazio, 00189
Study site
Rovigo, Veneto, 45100
Study site
S. Fermo Della Battaglia (CO), Lombardy, 22020
Study site
San Giovanni Rotondo, Apulia, 71013
Study site
Saronno, Lombardy, 21047
Study site
Sassari, Sardinia, 07100
Study site
Savona, Liguria
Study site
Siena, Tuscany, 53100
Study site
Sora, Lazio, 03039
Study site
Taormina, Sicily, 98030
Study site
Teramo, Abruzzo, 64100
Study site
Treviso, Veneto, 31100
Study site
Turin, Piedmont, 10126
Study site
Turin, Piedmont, 10153
Study site
Varese, Lombardy, 21100
Study site
Vimercate, Sicily, 20059
Study site
Viterbo, Lazio, 01100
About this study
Official title: 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.
- Conditions
- Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with Avastin treatment discontinuation due to either disease progression or Avastin-related adverse events
Measured: approximately 15 months
Secondary outcomes (4)
Proportion of patients with treatment discontinuation due to other causes
Measured: approximately 15 months
Incidence of other causes for treatment discontinuation
Measured: approximately 15 months
Second-line treatments initiated
Measured: 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)
Measured: approximately 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2012 (estimated)
- Study startJun 2012
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 437 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01609075
- Sponsor's protocol ID
- ML27907
- Status last verified
- Nov 2016
- First submitted
- 29 May 2012
- Last updated
- 2 Nov 2016
- Results posted
- No
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.
PubMed 30857495
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Bevacizumab in the Treatment of Metastatic Colorectal Cancer (mCRC) in Italy: an Observational Cohort Study
- ClinicalTrials.gov ID
- NCT01609075
- Acronym / sponsor ID
- ML27907
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 437 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 31 May 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with metastatic colorectal cancer having initiated first-line treatment with fluoropyrimidine-based chemotherapy and Avastin
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Participation in a clinical trial during treatment with Avastin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients with Avastin treatment discontinuation due to either disease progression or Avastin-related adverse events
Time frame: approximately 15 months
4 secondary outcomes
Proportion of patients with treatment discontinuation due to other causes
Time frame: approximately 15 months
Incidence of other causes for treatment discontinuation
Time frame: approximately 15 months
Second-line treatments initiated
Time frame: 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)
Time frame: approximately 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Derived from this study: PubMed 30857495Lonardi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
72 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Hoffmann-La Roche at 72 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 72 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with Avastin treatment discontinuation due to either disease progression or Avastin-related adverse events (time frame: approximately 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01609075, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.