REGISTRY OF COMPLETE RESPONSES TO SUNITINIB IN SPANISH PATIENTS WITH METASTATIC RENAL CELL CARCINOMA
ATILA
2 other identifiers
observational
62
1 country
31
Brief Summary
Observational, retrospective, multicentre study in spanish patients with metastatic Renal Cell Carcinoma (mRCC) treated with sunitinib as a first-line treatment (treatment with previous cytokine therapy is accepted) according to clinical practice who obtained a complete response (CR) to treatment in one of these 2 situations:
- 1.Complete response (CR) obtained exclusively with first-line sunitinib treatment (sunitinib CR).
- 2.Response obtained after a period of time on treatment with sunitinib in which local treatment was also performed (surgery of the residual metastasis/metastases, radiofrequency ablation or radiotherapy) to achieve the total macroscopic disappearance of the disease, according to the opinion of the physician responsible for the patient (CR + local treatment).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2019
Shorter than P25 for all trials
31 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 12, 2019
CompletedFirst Posted
Study publicly available on registry
April 16, 2019
CompletedStudy Start
First participant enrolled
December 17, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 3, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 3, 2020
CompletedResults Posted
Study results publicly available
December 13, 2021
CompletedDecember 13, 2021
October 1, 2021
11 months
April 12, 2019
October 29, 2021
October 29, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Time to Complete Remission of Lesions
Time to complete remission of lesions was calculated as the difference between treatment start date and complete response (CR) confirmation date. As per response evaluation criteria in solid tumors (RECIST) version (v) 1.1, CR = disappearance of all known target and all non-target lesions and the absence of new lesions, normalization of tumor markers. Pathological lymph nodes must have short axis measures \<10 millimeter (mm). CR was confirmed with 2 consecutive computed tomography (CT) scans performed with at least 4 weeks between them during the follow-up of participants. Confirmation from the oncologist and radiologist was required at each site.
From treatment initiation date to CR confirmation date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)
Duration of Complete Remission (DOR)
DOR was defined as the time from date on which the CR was identified until tumor progression, the change of treatment due to unacceptable toxicity, death from any cause or until the date of the last follow-up at the close of study. As per RECIST v1.1: CR = disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures \<10 mm. Tumor progression = at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) and an absolute increase of \>=5 mm or appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions.
From first documented CR date until progression/death or change of treatment due to unacceptable toxicity or last follow-up date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)
Progression Free Survival (PFS)
PFS was calculated as the time from the date of CR confirmation (2nd CT scan) until the date of progression/death or change of treatment for unacceptable toxicity or censored on the date of the last follow-up. As per RECIST v1.1: CR = disappearance of target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures \<10 mm. Tumor progression = at least a 20% increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including baseline) and an absolute increase of \>=5 mm or appearance of at least 1 new lesion. Unequivocal progression of existing non-target lesions. Analysis was performed using Kaplan-Meier method.
From CR confirmation date until progression/death or change of treatment due to unacceptable toxicity/last follow-up date, up to maximum of approximately 13 years (data collected, observed retrospectively for approximately 10 months)
Other Outcomes (9)
Time to Achieve CR in Participants Classified According to Heng I Criteria Prognosis
From treatment initiation date to CR confirmation date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)
Time to Achieve CR in Participants Classified According to Heng I Criteria Prognosis at Least 2 Consecutive CT Scans
From treatment initiation date to CR confirmation date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)
Time to Achieve CR in Participants Classified According to Previous Nephrectomy Status
From treatment initiation date to CR confirmation date, up to a maximum of approximately 13 years (from the data collected and observed retrospectively for approximately 10 months)
- +6 more other outcomes
Study Arms (1)
Subjects with reported metastatic renal cell carcinoma
The subjects have been treatment with sunitinib and they reached complete remission
Eligibility Criteria
The patient population eligible for this study includes any patient with advanced or metastatic renal cell cancer who has been treated with Sunitinib and has achieved CR of the tumour and its metastases at any time during treatment and according to the usual assessment criteria in daily clinical practice, whether it was obtained with sunitinib alone or if a local treatment was needed to eradicate all the lesions: (surgery of the residual metastases, radiofrequency ablation or radiotherapy)
You may qualify if:
- Patients who are 18 year-old or over who have been treated for metastatic renal cell carcinoma with sunitinib as first-line treatment (treatment with prior cytokine therapy is accepted) between 2007 and 30 September 2018 and who have obtained as a best treatment response the total remission of the disease in the opinion of the doctor in charge from a clinical, radiological and/or macroscopic point of view. This response must have been reached through two possible strategies:
- A) Systemic treatment with sunitinib alone. B) Treatment with sunitinib and subsequent local treatment for one or more residual lesions that have not responded to the drug (traditional surgery, radiotherapy, SBRT (Stereotactic Body Radiation Therapy)).
- The duration of CR must have been confirmed with at least 2 consecutive imaging tests, without having a limit in the duration of this response. Although the patient had progressed subsequently, he/she may be included in this registry.
- Patients from any risk group
- Tumours of any histology
You may not qualify if:
- Patients treated with another drug other than Sunitinib.
- Patients with no radiology reports proving CR.
- Patients with no record of the dose and regimen received with Sunitinib.
- Patients who achieved complete remission after 30 September 2018.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (31)
Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, 08908, Spain
Hospital San Juan de Dios
Manresa, Barcelona, 08243, Spain
Hospital Parc Taulí de Sabadell
Sabadell, Barcelona, 08208, Spain
Hospital Universitario Mutua Terrassa
Terrassa, Barcelona, 08221, Spain
Hospital Universitario de Marqués de Valdecilla
Santander, Cantabria, 39008, Spain
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, 28922, Spain
Hospital Universitario Severo Ochoa
Leganés, Madrid, 28911, Spain
Hospital Infanta Cristina
Parla, Madrid, 28981, Spain
Hospita Virgen de la Salud
Toledo, Madrid, 45004, Spain
Hospital Universitario Son Espases
Palma de Mallorca, Mallorca, 07120, Spain
Hospital Universitario Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Tenerife, 38010, Spain
Complexo Hospitalario Universitario de Ferrol
A Coruña, 15011, Spain
Hospital Universitario Infanta Cristina
Badajoz, 06080, Spain
Hospital del Mar
Barcelona, 08003, Spain
Hospital de la Santa Creu i Sant
Barcelona, 08041, Spain
Hospital Clínico de Barcelona
Barcelona, 08243, Spain
Hospital Universitario Reina Sofía
Córdoba, 14004, Spain
Hospital Universitario de Guadalajara
Guadalajara, 19002, Spain
Complejo Hospitalario de Jaén
Jaén, 23007, Spain
Hospital Universitario de León
León, 24080, Spain
Hospital Universitario Lucus Augusti / Servicio de Oncología Médica
Lugo, 27003, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Hospital Clínico San Carlos de Madrid
Madrid, 28040, Spain
Hospital Universitario 12 de octubre
Madrid, 28041, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Complexo Hospitalario Universitario de Ourense
Ourense, 32005, Spain
Complejo Asistencial de Segovia
Segovia, 40002, Spain
Hospital de Valme
Seville, 41014, Spain
Instituto Valenciano de Oncología
Valencia, 46009, Spain
Hospital Clínico Universitario de Valencia
Valencia, 46010, Spain
Hospital Universitario Doctor Peset
Valencia, 46017, Spain
Related Publications (1)
de Velasco G, Alonso-Gordoa T, Rodriguez-Vida A, Anguera G, Campayo M, Pinto A, Ortega EM, Gallardo E, Nunez NF, Garcia-Carbonero I, Reig O, Mendez-Vidal MJ, Fernandez-Calvo O, Cassinello NV, Torregrosa D, Lopez-Martin A, Rosero A, Valiente PG, de Espana CG, Climent MA, Santasusana MD, Sanchez AR, Gonzalez IC, Afonso R, Garcia Del Muro X, Casinello J, Fernandez-Parra EM, Garcia Sanchez L, Afonso J, Polo SH, Asensio U. Long-term Clinical Outcomes of a Spanish Cohort of Metastatic Renal Cell Carcinoma Patients with a Complete Response to Sunitinib. Clin Genitourin Cancer. 2023 Jun;21(3):e166-e174. doi: 10.1016/j.clgc.2022.11.021. Epub 2022 Dec 5.
PMID: 36610891DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 12, 2019
First Posted
April 16, 2019
Study Start
December 17, 2019
Primary Completion
November 3, 2020
Study Completion
November 3, 2020
Last Updated
December 13, 2021
Results First Posted
December 13, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will not share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.