Carcinoma, Non-Small-Cell LungNCT01877902
Study Of Use Of Pemetrexed In Patients With Non-Small Lung Cancer Metastatic In Andalusian Public Health System
An observational study of Carcinoma, Non-Small-Cell Lung, run by Fundación Pública Andaluza Progreso y Salud at 18 sites in Spain.
Trial summary
STUDY OF USE OF PEMETREXED IN PATIENTS WITH NON-SMALL LUNG CANCER METASTATIC IN ANDALUSIAN PUBLIC HEALTH SYSTEM Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Carcinoma, Non-Small-Cell Lung
- How many people
- 190 participants
- Where
- 18 sitesSpain
- Study dates
- Oct 2011to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: It will be included all patients diagnosed CPNMm participating centers to initiate treatment with pemetrexed in 1st line (either induction or maintenance.
Who may be able to join
- 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
Who cannot join
- Patients receiving pemetrexed within a clinical trial protocol because it is an experimental environment that does not reflect clinical practice.
Trial locations and contacts
18 sites in 1 country.
Javier Bautista Paloma contact
María del Mar Benjumea Vargas contact
18 sites in 1 country
Spain18 sites, 18 recruiting
- Recruiting
Hospital La Línea
Algeciras, Cádiz
José Carlos Roldán
- Recruiting
Hospital Punta de Europa
Algeciras, Cádiz
Pablo Villanueva Jiménez
- Recruiting
Hospital Universitario Torrecardenas
Almería
Juan José Fernández Avila
- Recruiting
Hospital de Baza
Baza, Granada
Francisco Nieto Cobo
- Recruiting
Hospital Universitario Puerta del Mar
Cadiz
María José Martínez Bautista
- Recruiting
Hospital Universitario Reina Sofía
Córdoba
Ana Isabel Gago Sánchez
- Recruiting
Hospital San Cecilio
Granada
Miguel Damas Fernández Fijares
- Recruiting
Hospital Santa Ana
Granada
Marcos Camacho Romera
- Recruiting
Hospital Universitario Virgen de las Nieves
Granada
Inmaculada Vallejo Rodríguez
- Recruiting
Hospital Universitario Juan Ramón Jiménez
Huelva
Mª Teresa Garrido Martínez
- Recruiting
Hospital Jerez de la Frontera
Jerez de la Frontera, Cádiz
Rocío Gavira Moreno
- Recruiting
Hospital Regional de Málaga
Málaga
Beatriz Mora Rodríguez
- Recruiting
Hospital Universitario Virgen de la Victoria
Málaga
Begoña Muros de Fuentes
- Recruiting
Hospital Costa del Sol
Marbella, Cádiz
Margarita Garrido
- Recruiting
Hospital de Puerto Real
Puerto Real, Cádiz
Carmen Martínez Díaz
- Recruiting
Hospital Universitario Virgen de Valme
Seville
Silvia Artecho
- Recruiting
Hospital Universitario Virgen del Rocío
Seville
Javier Bautista Paloma
- Recruiting
Hospital Universitario Virgen Macarena
Seville
Nuria Muñoz Muñoz
About this study
Official title: 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
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Pemetrexed 500 mg/m 2 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine utilization profile (line treatment and scheme used) of pemetrexed in patients with non-small cell lung cancer metastatic (CPNMm) in Andalusia.
Measured: 12 months
Secondary outcomes (1)
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2013 (estimated)
- Study startOct 2011
- Primary completionJan 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-Small-Cell LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza Progreso y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Javier Bautista Paloma, Principal investigator, Hospitales Universitarios Virgen del Rocío
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01877902
- Sponsor's protocol ID
- FPS-PEM-2013-06
- Status last verified
- Apr 2014
- First submitted
- 12 Jun 2013
- Last updated
- 5 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STUDY OF USE OF PEMETREXED IN PATIENTS WITH NON-SMALL LUNG CANCER METASTATIC IN ANDALUSIAN PUBLIC HEALTH SYSTEM
- ClinicalTrials.gov ID
- NCT01877902
- Acronym / sponsor ID
- FPS-PEM-2013-06
- Conditions
- Carcinoma, Non-Small-Cell Lung
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Fundación Pública Andaluza Progreso y SaludUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jan 2015 (estimated)
- First posted
- 14 Jun 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
STUDY OF USE OF PEMETREXED IN PATIENTS WITH NON-SMALL LUNG CANCER METASTATIC IN ANDALUSIAN PUBLIC HEALTH SYSTEM
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pemetrexed 500 mg/m 2 | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- It will be included all patients diagnosed CPNMm participating centers to initiate treatment with pemetrexed in 1st line (either induction or maintenance.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Patients receiving pemetrexed within a clinical trial protocol because it is an experimental environment that does not reflect clinical practice.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier Bautista Paloma contact
María del Mar Benjumea Vargas contact
Javier Bautista Paloma principal investigator
Hospitales Universitarios Virgen del Rocío
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Carcinoma, Non-Small-Cell Lung, run by Fundación Pública Andaluza Progreso y Salud at 18 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Javier Bautista Paloma (955 01 20 00), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2014.