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 study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01358942
First received: May 20, 2011
Last updated: April 7, 2014
Last verified: April 2014
  Purpose

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.


Condition
Non-Small Cell Lung Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official 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.

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Change in lung cancer related symptoms (LCSS questionnaire) [ Time Frame: up to approximately 6 months (4-6 cycles of chemotherapy) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency/severity of lung cancer related symptoms (LCSS questionnaire) [ Time Frame: approximately 2 years ] [ Designated as safety issue: No ]

Enrollment: 156
Study Start Date: May 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01358942

Locations
Spain
Vitoria, Alava, Spain, 01009
Alcoy, Alicante, Spain, 03804
Elche, Alicante, Spain, 03203
Elda, Alicante, Spain, 03600
Oviedo, Asturias, Spain, 33006
Jerez de La Frontera, Cadiz, Spain, 11407
San Sebastian, Guipuzcoa, Spain, 20080
Mahon, Islas Baleares, Spain, 07703
Palma de Mallorca, Islas Baleares, Spain, 07012
Palma de Mallorca, Islas Baleares, Spain, 07014
Logroño, La Rioja, Spain, 26006
Alcala de Henares, Madrid, Spain, 28805
Pamplona, Navarra, Spain, 31006
Pamplona, Navarra, Spain, 31008
Tudela, Navarra, Spain, 46010
Sagunto, Valencia, Spain, 46520
Xativa, Valencia, Spain, 46800
Bilbao, Vizcaya, Spain, 48013
Alicante, Spain, 3010
Barcelona, Spain, 08017
Barcelona, Spain, 08906
Barcelona, Spain, 08006
Castellon, Spain, 12002
Jaen, Spain, 23007
Madrid, Spain, 28050
Madrid, Spain, 28046
Madrid, Spain, 28041
Madrid, Spain, 28033
Madrid, Spain, 28040
Madrid, Spain, 28031
Malaga, Spain, 29010
Melilla, Spain, 52005
Navarra, Spain, 31008
Pontevedra, Spain, 36002
Segovia, Spain, 40002
Valencia, Spain, 46015
Valencia, Spain, 46017
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01358942     History of Changes
Other Study ID Numbers: ML25493
Study First Received: May 20, 2011
Last Updated: April 7, 2014
Health Authority: Spain: Ministry of Health

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 23, 2014