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

Completed

• Conditions: Colorectal Cancer

• Registration Number: NCT02287597
• Lead Sponsor: Hoffmann-La Roche

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-11-06
• Study First Submitted QC: 2014-11-06
• Study First Posted: 2014-11-10
• Study Start: 2014-11-13
• Primary Completion: 2018-03-21
• Study Completion: 2018-03-21
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-27
• Last Update Posted: 2018-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (4)

Clinical Hospital Osijek; Dept For Oncology & Radiotherapy; 🇭🇷 Osijek, Croatia

Uni Hospital Split; Oncology & Radiotherapy; 🇭🇷 Split, Croatia

Uni Hospital For Tumours; Dept of Medical Oncology; 🇭🇷 Zagreb, Croatia

Clinical Hospital Centre Zagreb; 🇭🇷 Zagreb, Croatia