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Completed

NCT Number: NCT01827852

AVAdeno Study: An Observational Study of First-Line Avastin (Bevacizumab) in Patients With Adenocarcinoma of the Lung

This prospective observational study will evaluate the efficacy and safety of first-line Avastin (bevacizumab) in combination with platinum-based chemotherapy in different age groups (<60, 60-69, 70-79, >80 years) in patients with inoperable advanced, metastatic or recurrent adenocarcinoma non-small cell lung cancer. Patients will be followed for 18 months from the start of first-line therapy.

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Key information

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universität Leipzig; Medizinische Klinik und Poliklinik I, Abteilung Pneumologie

Leipzig, 04103, Germany

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients, >/= 18 years of age
  • Histologically confirmed inoperable advanced, metastatic or recurrent pre-dominantly non-squamous adenocarcinoma non-small cell lung cancer

Exclusion criteria

  • Contraindications to Avastin treatment according to the Summary of Product Characteristics

Treatment and study plan

Primary outcomes

  1. Progression-free survival in 4 different age groups (<60, 60-69, 70-79, >/=80 years)

    Time frame: approximately 4.5 years

Secondary outcomes

  1. Overall survival in 4 different age groups (<60, 60-69, 70-79, >/=80 years)

    Time frame: approximately 4.5 years

  2. Clinical/demographic patient characteristics at initiation of treatment

    Time frame: approximately 4.5 years

  3. Avastin treatment schedule in routine clinical practice (dosage/duration)

    Time frame: approximately 4 years

  4. Concomitant anti-neoplastic therapy (dosage/duration)

    Time frame: approximately 4.5 years

  5. Safety: Incidence of adverse events in 4 different age groups (<60, 60-69, 70-79, >/=80 years)

    Time frame: approximately 4.5 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

AVAdeno: Non-interventional Study of Avastin 1st Line Therapy in Adenocarcinoma Patients of the Lung

Important dates

Study start
2013
Primary completion
2017
Study completion
2017
First posted
Apr 10, 2013
Registry last updated
Jul 28, 2017

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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