Study Of Use Of Pemetrexed In Patients With Non-Small Lung Cancer Metastatic In Andalusian Public Health System

December 4, 2014 updated by: Fundación Pública Andaluza Progreso y Salud

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

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

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

190

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Almería, Spain
        • Recruiting
        • Hospital Universitario Torrecárdenas
        • Contact:
          • Juan José Fernández Avila
      • Cádiz, Spain
        • Recruiting
        • Hospital Universitario Puerta Del Mar
        • Contact:
          • María José Martínez Bautista
      • Córdoba, Spain
        • Recruiting
        • Hospital Universitario Reina Sofia
        • Contact:
          • Ana Isabel Gago Sánchez
      • Granada, Spain
        • Recruiting
        • Hospital Universitario Virgen de las Nieves
        • Contact:
          • Inmaculada Vallejo Rodríguez
      • Granada, Spain
        • Recruiting
        • Hospital San Cecilio
        • Contact:
          • Miguel Damas Fernández Fijares
      • Granada, Spain
        • Recruiting
        • Hospital Santa Ana
        • Contact:
          • Marcos Camacho Romera
      • Huelva, Spain
        • Recruiting
        • Hospital Universitario Juan Ramon Jimenez
        • Contact:
          • Mª Teresa Garrido Martínez
      • Málaga, Spain
        • Recruiting
        • Hospital Universitario Virgen de la Victoria
        • Contact:
          • Begoña Muros de Fuentes
      • Málaga, Spain
        • Recruiting
        • Hospital Regional de Malaga
        • Contact:
          • Beatriz Mora Rodríguez
      • Sevilla, Spain
        • Recruiting
        • Hospital Universitario Virgen del Rocio
        • Contact:
          • Javier Bautista Paloma
      • Sevilla, Spain
        • Recruiting
        • Hospital Universitario Virgen Macarena
        • Contact:
          • Nuria Muñoz Muñoz
      • Sevilla, Spain
        • Recruiting
        • Hospital Universitario Virgen de Valme
        • Contact:
          • Silvia Artecho
    • Cádiz
      • Algeciras, Cádiz, Spain
        • Recruiting
        • Hospital La Línea
        • Contact:
          • José Carlos Roldán
      • Algeciras, Cádiz, Spain
        • Recruiting
        • Hospital Punta de Europa
        • Contact:
          • Pablo Villanueva Jiménez
      • Jerez de la Frontera, Cádiz, Spain
        • Recruiting
        • Hospital Jerez de la Frontera
        • Contact:
          • Rocío Gavira Moreno
      • Marbella, Cádiz, Spain
        • Recruiting
        • Hospital Costa Del Sol
        • Contact:
          • Margarita Garrido
      • Puerto Real, Cádiz, Spain
        • Recruiting
        • Hospital de Puerto Real
        • Contact:
          • Carmen Martínez Díaz
    • Granada
      • Baza, Granada, Spain
        • Recruiting
        • Hospital de Baza
        • Contact:
          • Francisco Nieto Cobo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Pemetrexed 500 mg/m 2

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine utilization profile (line treatment and scheme used) of pemetrexed in patients with non-small cell lung cancer metastatic (CPNMm) in Andalusia.
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Pública Andaluza Progreso y Salud

Investigators

  • Principal Investigator: Javier Bautista Paloma, Hospitales Universitarios Virgen del Rocío

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Anticipated)

January 1, 2015

Study Registration Dates

First Submitted

June 12, 2013

First Submitted That Met QC Criteria

June 13, 2013

First Posted (Estimate)

June 14, 2013

Study Record Updates

Last Update Posted (Estimate)

December 5, 2014

Last Update Submitted That Met QC Criteria

December 4, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FPS-PEM-2013-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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