Validation of the International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) Prognostic Classification for Targeted Therapies (TKI/mTOR Inhibitors) in Second Line After First Line Treatment With Pazopanib (Spazo-2)

April 25, 2018 updated by: Spanish Oncology Genito-Urinary Group

This is a nation-wide retrospective observational study which will be performed in 50 centres in Spain, geographically representative of all regions, with at least 5 patients treated with first-line pazopanib for mRCC in daily clinical practice since April 2011 (date of approval of pazopanib in Spain), January 2016.

Pazopanib is one of the standard tyrosine-kinase inhibitors (TKI) for the first-line treatment of metastatic renal cell carcinoma. In our previous SPAZO study, the Spanish Oncologic Genitourinary Group (SOGUG) validated the IMDC prognostic classification for patients receiving first-line pazopanib, and demonstrated the effectiveness of this drug in routine clinical practice. However, in this series of 278 patients, we could not obtain enough information on the effectiveness of pazopanib in special subpopulations such as non-clear cell histologies, and others subgroups, due to a small simple size of each of these subpopulations. On the other hand, after the results of RECORD-1 and AXIS trials, switching to everolimus or axitinib is the current approach for patients who progresses to a first-line TKI. However, these pivotal studies did not include patients treated with first-line pazopanib study because this drug was not available at that time. The results of the SPAZO study also suggested that the effectiveness of second-line targeted therapies (TT) after pazopanib in routine clinical practice is similar to the observed in clinical trials after sunitinib, sorafenib or bevacizumab. In addition, the preliminary results indicated that there are not meaningful differences in the effectiveness of TKI or mTOR inhibitors after pazopanib, when the results are adjusted by the IMDC prognostic classification. However, the IMDC prognostic classification for second-line TT has not yet been validated for patients who receive pazopanib as first-line. In addition our sample size was not large enough to make a comparison of effectiveness between mTOR inhibitors and antiVEGF for each prognostic subgroups of the IMDC.

Based on that, the Spanish Oncologic Genitourinary Group has decided to launch the SPAZO-2 study, in which we intend to prolong the follow up of patients included in SPAZO, and to increase the sample size with new patients from new centres, in order to obtain a larger sample in each of the subpopulations of interest, with the objective of obtaining more information about the above questions.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

530

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
      • Alicante, Spain, 03010
        • Hospital General Universitario de Alicante
      • Barcelona, Spain, 08003
        • Hospital del Mar
      • Barcelona, Spain, 08035
        • Hospital Universitario Vall d'Hebron
      • Barcelona, Spain, 08036
        • Hospital Clinic I Provincial De Barcelona
      • Barcelona, Spain, 08026
        • Hospital De La Santa Creu I Sant Pau
      • Burgos, Spain, 09006
        • Hospital Universitario de Burgos
      • Caceres, Spain, 10003
        • Hospital San Pedro de Alcantara
      • Ciudad Real, Spain, 13005
        • Hospital General Universitario de Ciudad Real
      • Cordoba, Spain, 14004
        • Hospital Universitario Reina Sofia
      • Granada, Spain, 18014
        • Hospital Universitario Virgen de las Nieves
      • Granada, Spain, 18012
        • Hospital Universitario Clínico San Cecilio
      • Guadalajara, Spain, 19002
        • Hospital Universitario de Guadalajara
      • Huelva, Spain, 21005
        • Hospital Juan Ramón Jimenez
      • Lugo, Spain, 27003
        • Hospital Universitario Lucus Augusti
      • Madrid, Spain, 28040
        • Fundación Jiménez Díaz
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Marañon
      • Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro
      • Madrid, Spain, 28003
        • Hospital La Luz
      • Madrid, Spain, 28047
        • Hospital Central de la Defensa "Gómez-Ulla"
      • Pontevedra, Spain, 36002
        • Hospital Provincial de Pontevedra
      • Salamanca, Spain, 37007
        • Hospital Universitario de Salamanca
      • Sevilla, Spain, 41013
        • Hospital Virgen del Rocío
      • Sevilla, Spain, 41009
        • Hospital Universitario Virgen De La Macarena
      • Sevilla, Spain, 41014
        • Hospital Nuestra Señora de Valme
      • Toledo, Spain, 45005
        • Hospital Virgen de la Salud
      • Valencia, Spain, 46009
        • Instituto Valenciano de Oncologia
      • Valencia, Spain, 46010
        • Hospital Clinico de Valencia
      • Valencia, Spain, 46017
        • Hospital Universitario Doctor Peset
      • Valencia, Spain, 46026
        • Hospital Universitario y Politecnico de la Fe
      • Valladolid, Spain, 47012
        • Hospital Universitario Rio Hortega
      • Zaragoza, Spain, 50009
        • Hospital Clinico Universitario Lozano Blesa
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Hospital General Universitario de Elche
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Hospital Germans Trias i Pujol
      • Sabadell, Barcelona, Spain, 08208
        • Corporacio Sanitaria Parc Tauli
      • Terrassa, Barcelona, Spain, 08221
        • Hospital Universitario Mútua Terrassa
    • Guipúzcoa
      • San Sebastian, Guipúzcoa, Spain, 20014
        • Onkologikoa
    • Jaén
      • Jaen, Jaén, Spain, 23007
        • Complejo Hospitalario de Jaen
    • La Coruña
      • Santiago de Compostela, La Coruña, Spain, 15706
        • Hospital Clinico Universitario de Santiago
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain, 35010
        • Hospital Universitario de Gran Canaria Dr. Negrin
    • León
      • Leon, León, Spain, 24001
        • Hospital Universitario de Leon
    • Madrid
      • Leganes, Madrid, Spain, 28911
        • Hospital Universitario Severo Ochoa
      • Pozuelo de Alarcon, Madrid, Spain, 28223
        • Hospital Universitario Quirón
      • San Sebastian de los Reyes, Madrid, Spain, 28703
        • Hospital Universitario Infanta Sofía
    • Mallorca
      • Palma de Mallorca, Mallorca, Spain, 07198
        • Hospital de Son Llàtzer
      • Palma de Mallorca, Mallorca, Spain, 07210
        • Hospital Universitario Son Espases
    • Ourense
      • Orense, Ourense, Spain, 32005
        • Complexo Hospitalario Universitario de Ourense
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36212
        • Hospital Alvaro Cunqueiro
    • Tarragona
      • Reus, Tarragona, Spain, 43204
        • Hospital Universitari Sant Joan de Reus
    • Tenerife
      • San Cristobal de La Laguna, Tenerife, Spain, 38320
        • Hospital Universitario de Canarias
      • Santa Cruz de Tenerife, Tenerife, Spain, 38010
        • Hospital Universitario Nuestra Señora de Candelaria
    • Valencia
      • Alcira, Valencia, Spain, 46600
        • Hospital Universitario de La Ribera
    • Vizcaya
      • Bilbao, Vizcaya, Spain, 48002
        • Hospital de Basurto
      • Bilbao, Vizcaya, Spain, 48014
        • Clinica IMQ Zorrotzaurre

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

metastatic renal cell carcinoma patients treated with pazopanib as first line treatment and target therapies (TKI/mTOR inhibitors) in second line

Description

Inclusion Criteria:

  • 1. Patients with confirmed mRCC. All histologies are allowed.
  • 2. Patients who have received pazopanib in their centre as first TKI for metastatic renal carcinoma in daily clinical practice since its approval in Spain until January 2016 (previous non-TKI therapies such as surgery for metastasis, local radiotherapy, citokines or chemotherapy are allowed.
  • 3. Age ≥18 years.
  • 4. Patients alive should give informed consent to participate in the study and to allow their medical records to be reviewed, preferably in writing o orally before independent witnesses of the research team and after being informed and have sufficient time to decide on their inclusion in the study

Exclusion Criteria:

  • 1. Patients who received pazopanib in any clinical trial, or who had received any systemic therapy prior to pazopanib will not be included, except citoquines or sunitinib providing it had been given as first-line, and switched to pazopanib due to toxicity or intolerance during the first cycle.

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
Metastatic Renal Cell Carcinoma patients
This is a nation-wide retrospective observational study with patients treated with first-line pazopanib for mRCC in daily clinical practice since April 2011 (date of approval of pazopanib in Spain), January 2016.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
IMDC prognostic
Time Frame: 1 day
Validate the IMDC prognostic classification in terms of overall survival, for second line treatment with mTOR/TKI inhibitors after first-line pazopanib. Overall survival defined as the period between second-line targeted therapy initiation and the date of death or censored on the day of last follow up visit, will be indirectly compared to the reported in the IMDC for the overall population and for each IMDC subgroups.
1 day

Secondary Outcome Measures

Outcome Measure
Time Frame
Effectiveness of mTOR inhibitors versus antiangiogenic TKI inhibitors in second-line after progression to pazopanib in the first-line setting of mRCC patients in terms of overall survival (OS).
Time Frame: 1 day
1 day
Effectiveness of mTOR inhibitors versus antiangiogenic TKI inhibitors in second-line after progression to pazopanib in the first-line setting of mRCC patients in terms of progression-free survival (PFS).
Time Frame: 1 day
1 day
Effectiveness of mTOR inhibitors versus antiangiogenic TKI inhibitors in second-line after progression to pazopanib in the first-line setting of mRCC patients in terms of response rate (RR).
Time Frame: 1 day
1 day
Effectiveness of pazopanib administered in the first-line setting of mRCC patients in terms of OS.
Time Frame: 1 day
1 day
Effectiveness of pazopanib administered in the first-line setting of mRCC patients in terms of PFS.
Time Frame: 1 day
1 day
Effectiveness of pazopanib administered in the first-line setting of mRCC patients in terms of RR.
Time Frame: 1 day
1 day
Safety of pazopanib and mTOR/TKI inhibitors evaluated as the number of patients who present treatment-related adverse events as assessed by CTCAE v4.0.
Time Frame: 1 day
1 day

Collaborators and Investigators

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

Sponsor

Spanish Oncology Genito-Urinary Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (ACTUAL)

December 20, 2016

Primary Completion (ACTUAL)

April 17, 2017

Study Completion (ACTUAL)

April 17, 2017

Study Registration Dates

First Submitted

March 2, 2017

First Submitted That Met QC Criteria

March 21, 2017

First Posted (ACTUAL)

March 27, 2017

Study Record Updates

Last Update Posted (ACTUAL)

April 26, 2018

Last Update Submitted That Met QC Criteria

April 25, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SOGUG-2016-A-IEC(REN)-4
  • SOG-PAZ-2016-01 (OTHER: The Spanish Agency of Medicinal Products and Medical Devices)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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