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Completed

NCT Number: NCT01893268

An Observational Study of Avastin (Bevacizumab) in Elderly Patients With Non-Squamous Non-Small Cell Lung Cancer in Clinical Practice

This prospective, observational study will assess the effectiveness and safety of Avastin (bevacizumab) as 1st line therapy in elderly patients with advanced non-squamous non-small cell lung cancer in clinical practice. Therapy with Avastin and standard chemotherapy will be administered according to the treating physician. Data will be collected for approximately 4 years.

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Key information

Conditions

Non-Squamous Non-Small Cell Lung Cancer

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinique Du Docteur Calabet; Cromg, Agen, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients, >= 65 years of age
  • Diagnosis of advanced non squamous Non-Small Cell Lung Carcinoma (nsNSCLC, stage IIIB or IV) for whom the physician has decided to initiate a treatment with Avastin combined with chemotherapy as 1st line therapy
  • Having received oral and written information about the study, and having signed a written consent form

Exclusion criteria

  • Participation in a cancer clinical trial with an investigational medicinal product other than this study
  • Patient previously treated with Avastin
  • Patient under supervision or guardianship

Treatment and study plan

Primary outcomes

  1. Proportion of patients treated with a chemotherapy in combination with Avastin including description of chemotherapy regimens and management of Avastin treatment

    Time frame: Approximately 4 years

Secondary outcomes

  1. Characteristics of patients with advanced non-squamous non-small cell lung cancer

    Time frame: Approximately 4 years

  2. Tumor characteristics of patients with advanced non-squamous non-small cell lung cancer

    Time frame: Approximately 4 years

  3. Progression-free survival

    Time frame: Approximately 4 years

  4. Overall survival

    Time frame: Approximately 4 years

  5. Quality of Life

    Time frame: Approximately 4 years

  6. Safety: Incidence of adverse events

    Time frame: Approximately 4 years

  7. Reasons of non-use of Avastin as first-line therapy

    Time frame: Approximately 4 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Therapeutic Strategies Including Avastin as 1st Line Therapy in Elderly Patients Suffering From Advanced (IIIB/IV Stage) Non-squamous Non-small Cell Lung Cancer, in Routine Clinical Practice.

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Jul 8, 2013
Registry last updated
May 14, 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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