Metastatic Renal Cell CarcinomaSpazo-2NCT03091465
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
An observational study of Metastatic Renal Cell Carcinoma, run by Spanish Oncology Genito-Urinary Group at 57 sites in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Renal Cell Carcinoma
- How many people
- 530 participants
- Where
- 57 sitesSpain
- Study dates
- 20 Dec 2016to 17 Apr 2017
- 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: metastatic renal cell carcinoma patients treated with pazopanib as first line treatment and target therapies (TKI/mTOR inhibitors) in second line
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
57 sites in 1 country.
57 sites in 1 country
Spain57 sites
Hospital General Universitario de Alicante
Alicante, 03010
Hospital Universitario de La Ribera
Alzira, Valencia, 46600
Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital del Mar
Barcelona, 08003
Hospital de la Santa Creu i Sant Pau
Barcelona, 08026
Hospital Universitario Vall D'Hebron
Barcelona, 08035
Hospital Clínic i Provincial de Barcelona
Barcelona, 08036
Hospital de Basurto
Bilbao, Vizcaya, 48002
Clínica IMQ Zorrotzaurre
Bilbao, Vizcaya, 48014
Hospital Universitario de Burgos
Burgos, 09006
Hospital San Pedro de Alcántara
Cáceres, 10003
Hospital General Universitario de Ciudad Real
Ciudad Real, 13005
Hospital Universitario Reina Sofía
Córdoba, 14004
Onkologikoa
Donostia / San Sebastian, Guipúzcoa, 20014
Hospital General Universitario de Elche
Elche, Alicante, 03203
Hospital Universitario Clínico San Cecilio
Granada, 18012
Hospital Universitario Virgen de las Nieves
Granada, 18014
Hospital Universitario de Guadalajara
Guadalajara, 19002
Hospital Juan Ramón Jimenez
Huelva, 21005
Complejo Hospitalario de Jaén
Jaén, Jaén, 23007
Hospital Universitario de Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria, Las Palmas, 35010
Hospital Universitario Severo Ochoa
Leganés, Madrid, 28911
Hospital Universitario de León
León, León, 24001
Hospital Universitario Lucus Augusti
Lugo, 27003
Hospital La Luz
Madrid, 28003
Hospital General Universitario Gregorio Marañón
Madrid, 28007
Fundación Jiménez Díaz
Madrid, 28040
Hospital Clínico San Carlos
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario La Paz
Madrid, 28046
Hospital Central de la Defensa "Gómez-Ulla"
Madrid, 28047
Hospital Universitario Puerta de Hierro
Madrid, 28222
Complexo Hospitalario Universitario de Ourense
Ourense, Ourense, 32005
Hospital de Son Llàtzer
Palma de Mallorca, Mallorca, 07198
Hospital Universitario Son Espases
Palma de Mallorca, Mallorca, 07210
Hospital Provincial de Pontevedra
Pontevedra, 36002
Hospital Universitario Quirón
Pozuelo de Alarcón, Madrid, 28223
Hospital Universitari Sant Joan de Reus
Reus, Tarragona, 43204
Corporació Sanitària Parc Taulí
Sabadell, Barcelona, 08208
Hospital Universitario de Salamanca
Salamanca, 37007
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Tenerife, 38320
Hospital Universitario Infanta Sofía
San Sebastián de los Reyes, Madrid, 28703
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Tenerife, 38010
Hospital Clínico Universitario de Santiago
Santiago de Compostela, La Coruña, 15706
Hospital Universitario Virgen de la Macarena
Seville, 41009
Hospital Virgen del Rocío
Seville, 41013
Hospital Nuestra Señora de Valme
Seville, 41014
Hospital Universitario Mútua Terrassa
Terrassa, Barcelona, 08221
Hospital Virgen de la Salud
Toledo, 45005
Instituto Valenciano de Oncología
Valencia, 46009
Hospital Clinico de Valencia
Valencia, 46010
Hospital Universitario Doctor Peset
Valencia, 46017
Hospital Universitario y Politécnico de La Fe
Valencia, 46026
Hospital Universitario Río Hortega
Valladolid, 47012
Hospital Álvaro Cunqueiro
Vigo, Pontevedra, 36212
Hospital Clínico Universitario Lozano Blesa
Zaragoza, 50009
Hospital Universitario Miguel Servet
Zaragoza, 50009
About this study
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.
- Conditions
- Metastatic Renal Cell Carcinoma
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
IMDC prognostic
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.
Measured: 1 day
Secondary outcomes (7)
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).
Measured: 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).
Measured: 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).
Measured: 1 day
Effectiveness of pazopanib administered in the first-line setting of mRCC patients in terms of OS.
Measured: 1 day
Effectiveness of pazopanib administered in the first-line setting of mRCC patients in terms of PFS.
Measured: 1 day
Effectiveness of pazopanib administered in the first-line setting of mRCC patients in terms of RR.
Measured: 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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start20 Dec 2016
- Primary completion17 Apr 2017
- Study completion17 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 530 participants (actual)
Sponsor and investigators
- Lead sponsor
- Spanish Oncology Genito-Urinary Group
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03091465
- Sponsor's protocol ID
- SOGUG-2016-A-IEC(REN)-4
- Other IDs
- SOG-PAZ-2016-01
- Acronym
- Spazo-2
- Status last verified
- Apr 2018
- First submitted
- 2 Mar 2017
- Last updated
- 26 Apr 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2010 Dec 15;127(12):2893-917. doi: 10.1002/ijc.25516.
PubMed 21351269Rini BI, Campbell SC, Escudier B. Renal cell carcinoma. Lancet. 2009 Mar 28;373(9669):1119-32. doi: 10.1016/S0140-6736(09)60229-4. Epub 2009 Mar 5.
PubMed 19269025
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
- 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
- ClinicalTrials.gov ID
- NCT03091465
- Acronym / sponsor ID
- Spazo-2 / SOGUG-2016-A-IEC(REN)-4
- Conditions
- Metastatic Renal Cell Carcinoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 530 participants (actual)
- Lead sponsor
- Spanish Oncology Genito-Urinary GroupUniversity, hospital or other
- Study start
- 20 Dec 2016 (actual)
- Primary completion
- 17 Apr 2017 (actual)
- Study completion
- 17 Apr 2017 (actual)
- First posted
- 27 Mar 2017 (actual)
- 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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- metastatic renal cell carcinoma patients treated with pazopanib as first line treatment and target therapies (TKI/mTOR inhibitors) in second line
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
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
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.
7 secondary outcomes
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
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
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
Effectiveness of pazopanib administered in the first-line setting of mRCC patients in terms of OS.
Time frame: 1 day
Effectiveness of pazopanib administered in the first-line setting of mRCC patients in terms of PFS.
Time frame: 1 day
Effectiveness of pazopanib administered in the first-line setting of mRCC patients in terms of RR.
Time frame: 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
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.
- Results publication: PubMed 21351269Ferlay J, Shin HR, Bray F, Forman D, Mathers C, Parkin DM. Estimates of worldwide burden of cancer in 2008: GLOBOCAN 2008. Int J Cancer. 2010 Dec 15;127(12):2893-917. doi: 10.1002/ijc.25516.
- Results publication: PubMed 19269025Rini BI, Campbell SC, Escudier B. Renal cell carcinoma. Lancet. 2009 Mar 28;373(9669):1119-32. doi: 10.1016/S0140-6736(09)60229-4. Epub 2009 Mar 5.
Related trials for Metastatic Renal Cell Carcinoma
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1/2
Pazopanib Hydrochloride and Bevacizumab in Treating Patients With Previously Untreated Metastatic Kidney Cancer
Clear Cell Renal Cell Carcinoma, Stage IV Renal Cell Cancer
RecruitingPhase 2
Phase II Trial of Combination Anti-PD-1 and Aldesleukin for Metastatic Melanoma and Renal Cell Carcinoma
Metastatic Melanoma, Advanced Locoregional Melanoma
Active, not recruitingPhase 1
P-MUC1C-ALLO1 Allogeneic CAR-T Cells in the Treatment of Subjects With Advanced or Metastatic Solid Tumors
Breast Cancer, Ovarian Cancer
RecruitingPhase 1
Open-Label Phase 1/2 Study of NEO-811 in Subjects With Locally Advanced or Metastatic Non-Resectable Clear Cell Renal Cell Carcinoma
Clear Cell Renal Cell Carcinoma, Renal Cell Carcinoma
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.
The record lists no contact. Use the official record to reach the sponsor.
57 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 57 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 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: 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 57 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?
IMDC prognostic (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03091465, which also lists 2 linked publications.
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.