Metastatic Renal Cell CarcinomaSPAZONCT02282579
Spanish Retrospective Study to Evaluate the Efficacy and Safety of Targeted Therapies After Pazopanib as First-line Therapy
An observational study of Metastatic Renal Cell Carcinoma, run by Spanish Oncology Genito-Urinary Group at 34 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Renal Cell Carcinoma
- What is being tested?
- Pazopanib
- How many people
- 300 participants
- Where
- 34 sitesSpain
- Study dates
- Oct 2014to Apr 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
34 sites in 1 country.
34 sites in 1 country
Spain34 sites
Hospital Clínic de Barcelona
Barcelona
Hospital Vall d' Hebron
Barcelona
Hospital San Pedro de Alcántara
Cáceres
Hospital G U de Ciudad Real
Ciudad Real
Hospital Reina Sofía
Córdoba
Hospital Universitario de Donostia
Donostia / San Sebastian
Hospital San Cecilio
Granada
Hospital General Gran Canaria Dr. Negrín
Las Palmas de Gran Canaria
Hospital de León
León
Hospital San Pedro Logroño
Logroño
Hospital Lucus Augusti
Lugo
Hospital Gregorio Marañon
Madrid, 28007
Fundacion Jimenez Diaz
Madrid
Hospital Clínico San Carlos
Madrid
Hospital Quirón
Madrid
Hospital U Puerta de Hierro Majadahonda
Madrid
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario La Paz
Madrid
Hospital Son Espases
Palma de Mallorca, Mallorca
Hospital Provincial de Pontevedra
Pontevedra
Hospital Clínico Universitario Salamanca
Salamanca
Hospital Universitario de Canarias
Santa Cruz de Tenerife
Hospital Marques de Valdecilla
Santander
Hospital Ntra. Sra. De Valme
Seville
Hospital Universitario Virgen del Rocío
Seville
Hospital Virgen de la Salud
Toledo
Hospital Clínico de Valencia
Valencia
Hospital Gral Universitario Valencia
Valencia
Hospital Universitario Dr. Peset
Valencia
IVO Valencia
Valencia
Hospital Rio Hortega
Valladolid
CHUVI ( Vigo)
Vigo
Hospital Lozano Blesa
Zaragoza
Hospital Miguel Servet
Zaragoza
About this study
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
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.
- Conditions
- Metastatic Renal Cell Carcinoma
- Being tested
- Pazopanib
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PazopanibDrug
Non interventional study
| Study group | Role | What they receive |
|---|---|---|
| Patient with metastatic renal cell carcinoma treated | Patient with metastatic renal cell carcinoma treated with Pazopanib Receives: Drug: Pazopanib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe the efficacy in terms of response
Describe the efficacy in terms of response of second-line targeted therapies administered in patients with metastatic clear cell carcinoma treated pazopanib as a first-line therapy in routine clinical practice (unselected population).
Measured: 3 years
Describe the efficacy in terms of progression-free survival (PFS)
Describe the efficacy in terms of progression-free survival (PFS) of second-line targeted therapies administered in patients with metastatic clear cell carcinoma treated pazopanib as a first-line therapy in routine clinical practice (unselected population).
Measured: 3 years
Describe the efficacy in terms of overall survival (OS)
Describe the efficacy in terms of overall survival (PFS) of second-line targeted therapies administered in patients with metastatic clear cell carcinoma treated pazopanib as a first-line therapy in routine clinical practice (unselected population).
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionFeb 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Renal Cell CarcinomaStudies 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spanish Oncology Genito-Urinary Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jose Arranz, PhD, Principal investigator, Investigator coordinator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02282579
- Sponsor's protocol ID
- SOG-SPA-2014-02
- Acronym
- SPAZO
- Status last verified
- Apr 2018
- First submitted
- 10 Sep 2014
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02282579
- Acronym / sponsor ID
- SPAZO / SOG-SPA-2014-02
- Conditions
- Metastatic Renal Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Spanish Oncology Genito-Urinary GroupUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 4 Nov 2014 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with metastatic renal cell carcinoma treated | – | Drug: PazopanibPatient with metastatic renal cell carcinoma treated with Pazopanib |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PazopanibNon interventional study | Drug | Patient with metastatic renal cell carcinoma treated |
Primary outcome
Describe the efficacy in terms of response
Time frame: 3 years
Describe the efficacy in terms of response of second-line targeted therapies administered in patients with metastatic clear cell carcinoma treated pazopanib as a first-line therapy in routine clinical practice (unselected population).
Describe the efficacy in terms of progression-free survival (PFS)
Time frame: 3 years
Describe the efficacy in terms of progression-free survival (PFS) of second-line targeted therapies administered in patients with metastatic clear cell carcinoma treated pazopanib as a first-line therapy in routine clinical practice (unselected population).
Describe the efficacy in terms of overall survival (OS)
Time frame: 3 years
Describe the efficacy in terms of overall survival (PFS) of second-line targeted therapies administered in patients with metastatic clear cell carcinoma treated pazopanib as a first-line therapy in routine clinical practice (unselected population).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2018.
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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.
Jose Arranz, PhD principal investigator
Investigator coordinator
34 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metastatic Renal Cell Carcinoma, run by Spanish Oncology Genito-Urinary Group at 34 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 4 inclusion and 2 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: finished, as of the sponsor's last update on 26 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 34 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe the efficacy in terms of response (time frame: 3 years). The study lists 3 primary outcomes in all. 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 26 Apr 2018.