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

November 1, 2016 updated by: Hoffmann-La Roche

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
437

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Cohort

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Proportion of patients with Avastin treatment discontinuation due to either disease progression or Avastin-related adverse events
Time Frame: approximately 15 months
approximately 15 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Proportion of patients with treatment discontinuation due to other causes
Time Frame: approximately 15 months
approximately 15 months
Incidence of other causes for treatment discontinuation
Time Frame: approximately 15 months
approximately 15 months
Second-line treatments initiated
Time Frame: approximately 15 months
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
approximately 15 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 29, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 29, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 31, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ML27907

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Colorectal Cancer

  • NCT04597151
    Completed
    Diet Education Program for Stage I-IV Colorectal Cancer Survivors
    Stage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8
  • NCT03781778
    Terminated
    Pilot Trial of Resistant Starch in Stage I-III Colorectal Cancer Survivors
    Rectal Cancer | Colon Cancer | Cancer Survivor | Colorectal Adenocarcinoma | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8
  • NCT04832763
    Active, not recruiting
    Medical and Psychosocial Issues in Adolescents and Young Adults With Colorectal Cancer
    Stage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8
  • NCT04739072
    Recruiting
    Minimal Residual Disease Assessment in Patients With Colorectal Cancer, the MiRDA-C Study
    Colorectal Adenocarcinoma | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8
  • NCT03796884
    Active, not recruiting
    Linaclotide in Treating Patients With Stages 0-3 Colorectal Cancer
    Colorectal Adenoma | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage 0 Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage IIA Colorectal Cancer AJCC v8 | Stage IIB Colorectal Cancer AJCC v8
  • NCT03844620
    Active, not recruiting
    Circulating Cell-Free Tumor DNA Testing in Guiding Treatment for Patients With Advanced or Metastatic Colorectal Cancer
    Stage IV Colorectal Cancer AJCC v8 | Stage IVA Colorectal Cancer AJCC v8 | Stage IVB Colorectal Cancer AJCC v8 | Stage IVC Colorectal Cancer AJCC v8 | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Refractory Colorectal Carcinoma
  • NCT03520283
    Completed
    Systems Support Mapping in Guiding Self-Management in Stage I-III Colorectal Cancer Survivors
    Cancer Survivor | Stage III Colorectal Cancer AJCC v8 | Stage IIIA Colorectal Cancer AJCC v8 | Stage IIIB Colorectal Cancer AJCC v8 | Stage IIIC Colorectal Cancer AJCC v8 | Stage I Colorectal Cancer AJCC v8 | Stage II Colorectal Cancer AJCC v8 | Stage IIA Colorectal Cancer AJCC v8 | Stage IIB Colorectal Cancer AJCC v8 | Stage IIC Colorectal Cancer AJCC v8
  • NCT03800602
    Completed
    Nivolumab and Metformin in Patients With Treatment Refractory MSS Colorectal Cancer
    Colorectal Cancer Metastatic | Colorectal Adenocarcinoma | Stage IV Colorectal Cancer | Stage IVA Colorectal Cancer | Stage IVB Colorectal Cancer | Refractory Colorectal Carcinoma | Metastatic Microsatellite Stable Colorectal Carcinoma | Stage IVC Colorectal Cancer
  • NCT01570452
    Completed
    Matrilysin Expression in Different Stages of Colorectal Tumors (MMP7)
    Colorectal Cancer Stage II | Colorectal Cancer Stage III | Colorectal Cancer Stage IV | Colorectal Cancer Stage 0 | Colorectal Cancer Stage I
  • NCT03300609
    Terminated
    5-FU Based Maintenance Therapy in RAS Wild Type Metastatic Colorectal Cancer After Induction With FOLFOX Plus Panitumumab
    Stage IV Colorectal Cancer AJCC v7 | Stage IVA Colorectal Cancer AJCC v7 | Stage IVB Colorectal Cancer AJCC v7 | Colorectal Adenocarcinoma | RAS Wild Type | Stage III Colorectal Cancer AJCC v7 | Stage IIIA Colorectal Cancer AJCC v7 | Stage IIIB Colorectal Cancer AJCC v7 | Stage IIIC Colorectal Cancer AJCC v7

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings