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OpenTrials
Completed

NCT Number: NCT01358942

An Observational Study of Lung Cancer Related Symptoms and Disease Control Rate in Patients With Non-Small Cell Lung Cancer Receiving First-Line Platinum-Based Chemotherapy With or Without Avastin (Bevacizumab)

This prospective observational study will evaluate the evolution of lung cancer related symptoms and their correlation with the disease control rate (complete response, partial response and stable disease) in patients with non-small cell lung cancer initiating first-line treatment with standard platinum-based chemotherapy with or without Avastin (bevacizumab). Data will be collected from each patient at baseline and after 4-6 cycles of chemotherapy.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Vitoria-Gasteiz, Alava, Spain

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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, >/= 18 years of age
  • Histologically or cytologically confirmed non-small cell lung cancer
  • Initiating first-line treatment with standard platinum-based chemotherapy, with or without bevacizumab

Exclusion criteria

  • Contraindications to the use of platinum-based chemotherapy

Treatment and study plan

Primary outcomes

  1. Change in lung cancer related symptoms (LCSS questionnaire)

    Time frame: up to approximately 6 months (4-6 cycles of chemotherapy)

  2. Correlation of lung cancer related symptoms and disease control rate (complete response, partial response, stable disease according to RECIST criteria)

    Time frame: approximately 2 years

Secondary outcomes

  1. Frequency/severity of lung cancer related symptoms (LCSS questionnaire)

    Time frame: approximately 2 years

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study title

Observational, Epidemiological and Non Interventional Study Evaluating the Evolution of Lung Cancer Related Symptoms and Its Correlation With Disease Control Rate in Patients With Non-Small Cell Lung Cancer (NSCLC) Initiating First-line Treatment With Platinum Based Standard Chemotherapy.

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 24, 2011
Registry last updated
Nov 2, 2016

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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