Clinical trial NCT02282579: Spanish Retrospective Study to Evaluate the Efficacy and Safety of Targeted Therapies After Pazopanib as First-line Therapy
Official title: Spanish Retrospective Study to Evaluate the Efficacy and Safety of Targeted Therapies After Pazopanib as First-line Therapy, in Patients With Metastatic Renal Cell Carcinoma in Daily Clinical Practice
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Metastatic Renal Cell Carcinoma
Lead sponsor: Spanish Oncology Genito-Urinary Group
Sponsor class: OTHER
First posted: 2014-11-04
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study is aimed at patients who received pazopanib in first-line metastatic cell renal cancer, so care (clinical trial patients are excluded) in the period from April 2011 (date of approval of pazopanib in Spain) to 30 June 2014, ie, before the presentation of CEICs in each hospital. In all cases, any decision to administer pazopanib therapy in first line will be taken according to local clinical practice and prior to the inclusion of patients in this retrospective study.

Brief summary: The purpose of this retrospective observational study was to analyze the effect of targeted therapies administered as second-line treatment after failure of pazopanib as well as increase the amount of information available on efficacy and safety of pazopanib as a first-line therapy in practice usual for the clinical treatment of metastatic Renal Carcinoma.


Eligibility criteria: Inclusion Criteria:

* Patients ≥ 18.
* Metastatic renal cell cancer of any histology.
* Patients treated with pazopanib for metastatic cell renal cancer outside the context of clinical trials (clinical practice) in Spanish centers from 1 April 2011 until 30 June 2014. shall be included all patients who received pazopanib as first-line treatment in each participating center, whether had experienced treatment failure with pazopanib or were still in first-line treatment. The inclusion of patients who are also allowed received cytokine as first-line treatment followed by pazopanib as well as patients who received sunitinib as first-line treatment and have changed pazopanib for toxicity or intolerance, provided they have not received more a cycle of sunitinib.
* Centers that agree to participate must commit to: · Include all patients meeting the inclusion criteria to reduce by possible selection bias. Because it supplies only pazopanib Hospital pharmacy service (not outside hospitals), the identification of patients will be performed at the hospital pharmacy records in each participating center.

Exclusion Criteria:

* Patients who received pazopanib in clinical trials or treatment second line, with the exceptions noted above.
* Patients with the diagnosis and / or treatment of malignancies of importance other than Cell renal cancer.

Primary outcomes:
measure: Describe the efficacy in terms of response
timeFrame: 3 years
measure: Describe the efficacy in terms of progression-free survival (PFS)
timeFrame: 3 years
measure: Describe the efficacy in terms of overall survival (OS)
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Palma De Mallorca
country: Spain
facility: Hospital Son Espases
state: Mallorca
city: Barcelona
country: Spain
facility: Hospital Clínic de Barcelona
city: Barcelona
country: Spain
facility: Hospital Vall d' Hebron
city: Caceres
country: Spain
facility: Hospital San Pedro de Alcántara
city: Ciudad Real
country: Spain
facility: Hospital G U de Ciudad Real
city: Cordoba
country: Spain
facility: Hospital Reina Sofía
city: Donostia
country: Spain
facility: Hospital Universitario de Donostia
city: Granada
country: Spain
facility: Hospital San Cecilio
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital General Gran Canaria Dr. Negrín
city: León
country: Spain
facility: Hospital de León
city: Logroño
country: Spain
facility: Hospital San Pedro Logroño
city: Lugo
country: Spain
facility: Hospital Lucus Augusti
city: Madrid
country: Spain
facility: Hospital Gregorio Marañon
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Quirón
city: Madrid
country: Spain
facility: Hospital U Puerta de Hierro Majadahonda
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Pontevedra
country: Spain
facility: Hospital Provincial de Pontevedra
city: Salamanca
country: Spain
facility: Hospital Clínico Universitario Salamanca
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Universitario de Canarias
city: Santander
country: Spain
facility: Hospital Marques de Valdecilla
city: Sevilla
country: Spain
facility: Hospital Ntra. Sra. De Valme
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud
city: Valencia
country: Spain
facility: Hospital Clínico de Valencia
city: Valencia
country: Spain
facility: Hospital Gral Universitario Valencia
city: Valencia
country: Spain
facility: Hospital Universitario Dr. Peset
city: Valencia
country: Spain
facility: IVO Valencia
city: Valladolid
country: Spain
facility: Hospital Rio Hortega
city: Vigo
country: Spain
facility: CHUVI ( Vigo)
city: Zaragoza
country: Spain
facility: Hospital Lozano Blesa
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
Study officials:
affiliation: Investigator coordinator
name: Jose Arranz, PhD
role: PRINCIPAL_INVESTIGATOR
References: