Clinical trial NCT01877902: Study Of Use Of Pemetrexed In Patients With Non-Small Lung Cancer Metastatic In Andalusian Public Health System
Official title: STUDY OF USE OF PEMETREXED IN PATIENTS WITH NON-SMALL LUNG CANCER METASTATIC IN ANDALUSIAN PUBLIC HEALTH SYSTEM
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Andalusian Network for Design and Translation of Advanced Therapies
Sponsor class: OTHER
First posted: 2013-06-14
Enrollment: 190
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: It will be included all patients diagnosed CPNMm participating centers to initiate treatment with pemetrexed in 1st line (either induction or maintenance.

Brief summary: STUDY OF USE OF PEMETREXED IN PATIENTS WITH NON-SMALL LUNG CANCER METASTATIC IN ANDALUSIAN PUBLIC HEALTH SYSTEM


Eligibility criteria: Inclusion Criteria:

* Patients over 18 years
* Confirmed diagnosis of metastatic NSCLC
* Pemetrexed Starts 1st line (either induction or maintenance) in any of the following periods:
* January 1, 2010 to March 31, 2010
* October 1, 2011 to December 31, 2011

Exclusion Criteria:

* Patients receiving pemetrexed within a clinical trial protocol because it is an experimental environment that does not reflect clinical practice.

Primary outcomes:
measure: Determine utilization profile (line treatment and scheme used) of pemetrexed in patients with non-small cell lung cancer metastatic (CPNMm) in Andalusia.
timeFrame: 12 months
Secondary outcomes:
measure: 1) Determine the progression-free survival and overall survival 2) Evaluate the degree of adherence in prescribing pemetrexed patients with CPNMm in Andalusia approved indications, the recommendations of the Pharmacy and Therapeutics Committees and
timeFrame: 12 months
Other outcomes:
Locations:
city: Algeciras
country: Spain
facility: Hospital La Línea
state: Cádiz
city: Algeciras
country: Spain
facility: Hospital Punta de Europa
state: Cádiz
city: Jerez de la Frontera
country: Spain
facility: Hospital Jerez de la Frontera
state: Cádiz
city: Marbella
country: Spain
facility: Hospital Costa del Sol
state: Cádiz
city: Puerto Real
country: Spain
facility: Hospital de Puerto Real
state: Cádiz
city: Baza
country: Spain
facility: Hospital de Baza
state: Granada
city: Almería
country: Spain
facility: Hospital Universitario Torrecardenas
city: Cádiz
country: Spain
facility: Hospital Universitario Puerta del Mar
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Granada
country: Spain
facility: Hospital San Cecilio
city: Granada
country: Spain
facility: Hospital Santa Ana
city: Granada
country: Spain
facility: Hospital Universitario Virgen de las Nieves
city: Huelva
country: Spain
facility: Hospital Universitario Juan Ramón Jiménez
city: Málaga
country: Spain
facility: Hospital Regional de Málaga
city: Málaga
country: Spain
facility: Hospital Universitario Virgen de la Victoria
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de Valme
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
Study officials:
affiliation: Hospitales Universitarios Virgen del Rocío
name: Javier Bautista Paloma
role: PRINCIPAL_INVESTIGATOR
References: