Clinical trial NCT01525199: Diagnosis and Treatment Strategies in Patients With NSCLC With or Without EGFR Mutations.
Official title: Study of Cases and Controls on Diagnosis and Treatment Strategies in Patients With NSCLC With or Without EGFR Mutations.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stage IIIB/IV
Non-Small Cell Lung Cancer
Keywords: Non-Small Cell Lung Cancer,
Epidermal Growth Factor Receptor mutation,
Lung cancer,
Lung adenocarcinoma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2012-02-02
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from specialized sites; all the participating investigators will be oncologists.

Brief summary: The purpose of this trial is to compare the evolution of patients receiving first line treatment for locally advanced or metastatic lung cancer, taking into account if they were requested or not the EGFR mutation test as part of the diagnosis and treatment strategy. There is no assignment to any particular therapeutic strategy.

Detailed description: Study of cases and controls on diagnosis and treatment strategies in patients with NSCLC with or without EGFR mutations.

Eligibility criteria: Inclusion Criteria:

* Patients with confirmed diagnosis of lung adenocarcinoma, stage IIIb/IV.
* Patients under 1st line treatment against lung adenocarcinoma.

Exclusion Criteria:

* Patients not having the information required by the protocol.

Primary outcomes:
measure: Disease free survival
timeFrame: 12 months after the diagnosis of advanced disease
measure: Overall Survival
timeFrame: 12 months after the diagnosis of advanced disease
measure: Number of hospitalizations
timeFrame: 12 months after the diagnosis of advanced disease
Secondary outcomes:
Other outcomes:
Locations:
city: Bahia Blanca
country: Argentina
facility: Research Site
state: Buenos Aires
city: Bolivar
country: Argentina
facility: Research Site
state: Buenos Aires
city: Ciudad de Buenos Aires
country: Argentina
facility: Research Site
state: Buenos Aires
city: Junin
country: Argentina
facility: Research Site
state: Buenos Aires
city: La Plata
country: Argentina
facility: Research Site
state: Buenos Aires
city: Lanus
country: Argentina
facility: Research Site
state: Buenos Aires
city: Lomas de Zamora
country: Argentina
facility: Research Site
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Research Site
state: Buenos Aires
city: Santa Rosa
country: Argentina
facility: Research Site
state: La Pampa
city: Gral. Roca
country: Argentina
facility: Research Site
state: Rio Negro
city: Rosario
country: Argentina
facility: Research Site
state: Santa Fe
city: Cordoba
country: Argentina
facility: Research Site
city: La Rioja
country: Argentina
facility: Research Site
city: Mendoza
country: Argentina
facility: Research Site
city: San Luis
country: Argentina
facility: Research Site
city: Santa Fe
country: Argentina
facility: Research Site
city: Tucuman
country: Argentina
facility: Research Site
Study officials:
References: