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

Colorectal Cancer Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02287597
• Other study ID #: ML29055
• Status: Completed
• Start date: November 13, 2014
• Est. completion date: March 21, 2018

Study information

• Verified date: July 2018
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 21, 2018
• Est. primary completion date: March 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Locations

Country	Name	City	State
Croatia	Clinical Hospital Osijek; Dept For Oncology & Radiotherapy	Osijek
Croatia	Uni Hospital Split; Oncology & Radiotherapy	Split
Croatia	Clinical Hospital Centre Zagreb	Zagreb
Croatia	Uni Hospital For Tumours; Dept of Medical Oncology	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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