Clinical trial 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)
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non-Squamous Non-Small Cell Lung Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-05-24
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Non-small cell lung cancer patients initiating treatment with platinum-based chemotherapy +/- bevacizumab

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.


Eligibility 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

Primary outcomes:
measure: Change in lung cancer related symptoms (LCSS questionnaire)
timeFrame: up to approximately 6 months (4-6 cycles of chemotherapy)
measure: Correlation of lung cancer related symptoms and disease control rate (complete response, partial response, stable disease according to RECIST criteria)
timeFrame: approximately 2 years
Secondary outcomes:
measure: Frequency/severity of lung cancer related symptoms (LCSS questionnaire)
timeFrame: approximately 2 years
Other outcomes:
Locations:
city: Vitoria
country: Spain
state: Alava
city: Alcoy
country: Spain
state: Alicante
city: Elche
country: Spain
state: Alicante
city: Elda
country: Spain
state: Alicante
city: Oviedo
country: Spain
state: Asturias
city: Jerez de La Frontera
country: Spain
state: Cadiz
city: San Sebastian
country: Spain
state: Guipuzcoa
city: Mahon
country: Spain
state: Islas Baleares
city: Palma de Mallorca
country: Spain
state: Islas Baleares
city: Palma de Mallorca
country: Spain
state: Islas Baleares
city: Logroño
country: Spain
state: La Rioja
city: Alcala de Henares
country: Spain
state: Madrid
city: Melilla
country: Spain
state: Malaga
city: Pamplona
country: Spain
state: Navarra
city: Pamplona
country: Spain
state: Navarra
city: Tudela
country: Spain
state: Navarra
city: Sagunto
country: Spain
state: Valencia
city: Xativa
country: Spain
state: Valencia
city: Bilbao
country: Spain
state: Vizcaya
city: Alicante
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Barcelona
country: Spain
city: Castellon
country: Spain
city: Jaen
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Madrid
country: Spain
city: Malaga
country: Spain
city: Navarra
country: Spain
city: Pontevedra
country: Spain
city: Segovia
country: Spain
city: Valencia
country: Spain
city: Valencia
country: Spain
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: