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

July 25, 2017 updated by: Hoffmann-La Roche

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

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

1107

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Leipzig, Germany, 04103
        • Universität Leipzig; Medizinische Klinik und Poliklinik I, Abteilung Pneumologie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with inoperable advanced, metastatic or recurrent predominantly non-squamous adenocarcinoma non-small cell lung cancer

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression-free survival in 4 different age groups (<60, 60-69, 70-79, >/=80 years)
Time Frame: approximately 4.5 years
approximately 4.5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival in 4 different age groups (<60, 60-69, 70-79, >/=80 years)
Time Frame: approximately 4.5 years
approximately 4.5 years
Clinical/demographic patient characteristics at initiation of treatment
Time Frame: approximately 4.5 years
approximately 4.5 years
Avastin treatment schedule in routine clinical practice (dosage/duration)
Time Frame: approximately 4 years
approximately 4 years
Concomitant anti-neoplastic therapy (dosage/duration)
Time Frame: approximately 4.5 years
approximately 4.5 years
Safety: Incidence of adverse events in 4 different age groups (<60, 60-69, 70-79, >/=80 years)
Time Frame: approximately 4.5 years
approximately 4.5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2013

Primary Completion (Actual)

May 31, 2017

Study Completion (Actual)

May 31, 2017

Study Registration Dates

First Submitted

April 2, 2013

First Submitted That Met QC Criteria

April 9, 2013

First Posted (Estimate)

April 10, 2013

Study Record Updates

Last Update Posted (Actual)

July 28, 2017

Last Update Submitted That Met QC Criteria

July 25, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML28306

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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