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)

November 1, 2016 updated by: Hoffmann-La Roche

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.

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

156

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

  • Spain
      • Alicante, Spain, 3010
      • Barcelona, Spain, 08906
      • Barcelona, Spain, 08006
      • Barcelona, Spain, 08017
      • Castellon, Spain, 12002
      • Jaen, Spain, 23007
      • Madrid, Spain, 28040
      • Madrid, Spain, 28046
      • Madrid, Spain, 28041
      • Madrid, Spain, 28033
      • Madrid, Spain, 28050
      • Madrid, Spain, 28031
      • Malaga, Spain, 29010
      • Navarra, Spain, 31008
      • Pontevedra, Spain, 36002
      • Segovia, Spain, 40002
      • Valencia, Spain, 46017
      • Valencia, Spain, 46015
    • Alava
      • Vitoria, Alava, Spain, 01009
    • Alicante
      • Alcoy, Alicante, Spain, 03804
      • Elche, Alicante, Spain, 03203
      • Elda, Alicante, Spain, 03600
    • Asturias
      • Oviedo, Asturias, Spain, 33011
    • Cadiz
      • Jerez de La Frontera, Cadiz, Spain, 11407
    • Guipuzcoa
      • San Sebastian, Guipuzcoa, Spain, 20080
    • Islas Baleares
      • Mahon, Islas Baleares, Spain, 07703
      • Palma de Mallorca, Islas Baleares, Spain, 07014
      • Palma de Mallorca, Islas Baleares, Spain, 07012
    • La Rioja
      • Logroño, La Rioja, Spain, 26006
    • Madrid
      • Alcala de Henares, Madrid, Spain, 28805
    • Malaga
      • Melilla, Malaga, Spain, 52005
    • Navarra
      • Pamplona, Navarra, Spain, 31008
      • Pamplona, Navarra, Spain, 31006
      • Tudela, Navarra, Spain, 46010
    • Valencia
      • Sagunto, Valencia, Spain, 46520
      • Xativa, Valencia, Spain, 46800
    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48013

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

Non-small cell lung cancer patients initiating treatment with platinum-based chemotherapy +/- bevacizumab

Description

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

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

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in lung cancer related symptoms (LCSS questionnaire)
Time Frame: up to approximately 6 months (4-6 cycles of chemotherapy)
up to approximately 6 months (4-6 cycles of chemotherapy)
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
approximately 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Frequency/severity of lung cancer related symptoms (LCSS questionnaire)
Time Frame: approximately 2 years
approximately 2 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

May 1, 2011

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

May 20, 2011

First Submitted That Met QC Criteria

May 20, 2011

First Posted (Estimate)

May 24, 2011

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML25493

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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