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)
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.
1 other identifier
observational
156
1 country
37
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2011
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 20, 2011
CompletedFirst Posted
Study publicly available on registry
May 24, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2012
CompletedNovember 2, 2016
November 1, 2016
1.5 years
May 20, 2011
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Change in lung cancer related symptoms (LCSS questionnaire)
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)
approximately 2 years
Secondary Outcomes (1)
Frequency/severity of lung cancer related symptoms (LCSS questionnaire)
approximately 2 years
Study Arms (1)
Cohort
Eligibility Criteria
Non-small cell lung cancer patients initiating treatment with platinum-based chemotherapy +/- bevacizumab
You may qualify if:
- 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
You may not qualify if:
- Contraindications to the use of platinum-based chemotherapy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (37)
Unknown Facility
Vitoria-Gasteiz, Alava, 01009, Spain
Unknown Facility
Alcoy, Alicante, 03804, Spain
Unknown Facility
Alicante, Alicante, 3010, Spain
Unknown Facility
Elche, Alicante, 03203, Spain
Unknown Facility
Elda, Alicante, 03600, Spain
Unknown Facility
Maó, Balearic Islands, 07703, Spain
Unknown Facility
Palma de Mallorca, Balearic Islands, 07012, Spain
Unknown Facility
Palma de Mallorca, Balearic Islands, 07014, Spain
Unknown Facility
Barcelona, Barcelona, 08006, Spain
Unknown Facility
Barcelona, Barcelona, 08017, Spain
Unknown Facility
Barcelona, Barcelona, 08906, Spain
Unknown Facility
Jerez de la Frontera, Cadiz, 11407, Spain
Unknown Facility
Castellon, Castellon, 12002, Spain
Unknown Facility
Donostia / San Sebastian, Guipuzcoa, 20080, Spain
Unknown Facility
Jaén, Jaen, 23007, Spain
Unknown Facility
Logroño, La Rioja, 26006, Spain
Unknown Facility
Alcalá de Henares, Madrid, 28805, Spain
Unknown Facility
Madrid, Madrid, 28031, Spain
Unknown Facility
Madrid, Madrid, 28033, Spain
Unknown Facility
Madrid, Madrid, 28040, Spain
Unknown Facility
Madrid, Madrid, 28041, Spain
Unknown Facility
Madrid, Madrid, 28046, Spain
Unknown Facility
Madrid, Madrid, 28050, Spain
Unknown Facility
Málaga, Malaga, 29010, Spain
Unknown Facility
Melilla, Malaga, 52005, Spain
Unknown Facility
Navarra, Navarre, 31008, Spain
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Pamplona, Navarre, 31006, Spain
Unknown Facility
Pamplona, Navarre, 31008, Spain
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Tudela, Navarre, 46010, Spain
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Pontevedra, Pontevedra, 36002, Spain
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Oviedo, Principality of Asturias, 33011, Spain
Unknown Facility
Segovia, Segovia, 40002, Spain
Unknown Facility
Sagunto, Valencia, 46520, Spain
Unknown Facility
Valencia, Valencia, 46015, Spain
Unknown Facility
Valencia, Valencia, 46017, Spain
Unknown Facility
Xàtiva, Valencia, 46800, Spain
Unknown Facility
Bilbao, Vizcaya, 48013, Spain
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2011
First Posted
May 24, 2011
Study Start
May 1, 2011
Primary Completion
November 1, 2012
Study Completion
November 1, 2012
Last Updated
November 2, 2016
Record last verified: 2016-11