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Completed

NCT Number: NCT02287597

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

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.

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Effectiveness: Second-line time to progression, in months

    Time frame: 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 outcomes

  1. 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

    Time frame: Up to 2 years

  2. 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

    Time frame: Up to 2 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Nov 10, 2014
Registry last updated
Jul 30, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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