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REGISTRY OF COMPLETE RESPONSES TO SUNITINIB IN SPANISH PATIENTS WITH METASTATIC RENAL CELL CARCINOMA

NCT ID: NCT03916458

Last Updated: 2021-12-13

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

62 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-12-17

Study Completion Date

2020-11-03

Brief Summary

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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).

Detailed Description

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Conditions

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Carcinoma, Renal Cell

Keywords

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Carcinoma, Renal Cell Disease-Free Survival Sunitinib Protein Kinase Inhibitors Angiogenesis Inhibitors Prognosis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

RETROSPECTIVE

Study Groups

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Subjects with reported metastatic renal cell carcinoma

The subjects have been treatment with sunitinib and they reached complete remission

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. 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)).
2. 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.
3. Patients from any risk group
4. Tumours of any histology

Exclusion Criteria

1. Patients treated with another drug other than Sunitinib.
2. Patients with no radiology reports proving CR.
3. Patients with no record of the dose and regimen received with Sunitinib.
4. Patients who achieved complete remission after 30 September 2018.
Minimum Eligible Age

18 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Hospital Duran i Reynals

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Hospital San Juan de Dios

Manresa, Barcelona, Spain

Site Status

Hospital Parc Taulí de Sabadell

Sabadell, Barcelona, Spain

Site Status

Hospital Universitario Mutua Terrassa

Terrassa, Barcelona, Spain

Site Status

Hospital Universitario de Marqués de Valdecilla

Santander, Cantabria, Spain

Site Status

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, Spain

Site Status

Hospital Universitario Severo Ochoa

Leganés, Madrid, Spain

Site Status

Hospital Infanta Cristina

Parla, Madrid, Spain

Site Status

Hospita Virgen de la Salud

Toledo, Madrid, Spain

Site Status

Hospital Universitario Son Espases

Palma de Mallorca, Mallorca, Spain

Site Status

Hospital Universitario Nuestra Señora de Candelaria

Santa Cruz de Tenerife, Tenerife, Spain

Site Status

Complexo Hospitalario Universitario de Ferrol

A Coruña, , Spain

Site Status

Hospital Universitario Infanta Cristina

Badajoz, , Spain

Site Status

Hospital del Mar

Barcelona, , Spain

Site Status

Hospital de la Santa Creu i Sant

Barcelona, , Spain

Site Status

Hospital Clínico de Barcelona

Barcelona, , Spain

Site Status

Hospital Universitario Reina Sofía

Córdoba, , Spain

Site Status

Hospital Universitario de Guadalajara

Guadalajara, , Spain

Site Status

Complejo Hospitalario de Jaén

Jaén, , Spain

Site Status

Hospital Universitario de León

León, , Spain

Site Status

Hospital Universitario Lucus Augusti / Servicio de Oncología Médica

Lugo, , Spain

Site Status

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Site Status

Hospital Clínico San Carlos de Madrid

Madrid, , Spain

Site Status

Hospital Universitario 12 de octubre

Madrid, , Spain

Site Status

Hospital Universitario La Paz

Madrid, , Spain

Site Status

Complexo Hospitalario Universitario de Ourense

Ourense, , Spain

Site Status

Complejo Asistencial de Segovia

Segovia, , Spain

Site Status

Hospital de Valme

Seville, , Spain

Site Status

Instituto Valenciano de Oncología

Valencia, , Spain

Site Status

Hospital Clínico Universitario de Valencia

Valencia, , Spain

Site Status

Hospital Universitario Doctor Peset

Valencia, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 36610891 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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https://pmiform.com/clinical-trial-info-request?StudyID=A6181227

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Other Identifiers

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ATILA

Identifier Type: OTHER

Identifier Source: secondary_id

A6181227

Identifier Type: -

Identifier Source: org_study_id