An Observational Study of Avastin (Bevacizumab) in Patients With Metastatic Colorectal Cancer: Continued Avastin Plus Chemotherapy After First Progression in Clinical Practice

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02287597

Enrollment

Registered

2014-11-10

Start date

2014-11-13

Completion date

2018-03-21

Last updated

2018-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

Brief summary

This local, non-interventional, cohort study of patients with metastatic colorectal cancer (mCRC) will prospectively collect data from standard clinical practice of second-line treatment with chemotherapy plus Avastin (bevacizumab). There will be no additional diagnostic or therapeutic procedures required by this study, apart from those performed in everyday clinical practice for second-line treatment of mCRC in Croatia.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Written informed consent * Age \>/=18 years * Metastatic colorectal cancer (mCRC) previously treated with systemic treatment for advanced disease containing Avastin and chemotherapy; first-line Avastin received according to the Summary of Product Characteristics (SmPC) * First line progression-free survival (PFS) \>6 months * Eligible for second-line chemotherapy regimen * Period between first progression and start of second line treatment with Avastin and chemotherapy \</=6 weeks

Exclusion criteria

* Contraindications, warnings and precautions for use specified in the Avastin SmPC

Design outcomes

Primary

Measure	Time frame
Effectiveness: Second-line time to progression, in months	Time between treatment initiation and tumor progression or death from cancer related cause, with censoring of patients who are lost to follow-up; up to 2 years

Secondary

Measure	Time frame
Safety (composite outcome measure): Incidence of all adverse events, adverse events of special interest (AESI) for bevacizumab and pregnancies reported in second line mCRC treatment with Avastin plus chemotherapy	Up to 2 years
Safety (composite outcome measure): Incidence, nature and severity of all serious adverse events reported in second line mCRC treatment with Avastin plus chemotherapy and information on outcome and action taken with the drug	Up to 2 years

Countries

Croatia

Outcome results