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Spots Global Cancer Trial Database for Clinical Trial With Vinflunine as Maintenance Therapy in Metastatic Urothelial Cancer

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Trial Identification

Brief Title: Clinical Trial With Vinflunine as Maintenance Therapy in Metastatic Urothelial Cancer

Official Title: Randomized Phase II Study of Vinflunine as Maintenance Monotherapy in Patients With Advanced or Metastatic Urothelial Cancer That Obtains Clinical Benefit of the First Line With Cisplatin-gemcitabine Combination

Study ID: NCT01529411

Study Description

Brief Summary: This is a clinical trial to evaluate the efficacy and safety of the drug vinflunine administered after the standard treatment of the combination gemcitabine+cisplatin, when it has reached stabilization or response of the disease, as the first treatment inmeditely after the diagnosis of advanced or metastatic urothelial cancer.

Detailed Description: Vinflunine is a drug recently approved in Europe for the treatment of advanced or metastatic urothelial cancer after platinum-failure. It has proved to improve the survival results compared with the best suportive care. In adition, the tolerability was favourable, specially for not leading appearance of neuropathy nor other cumulative toxic effects. In this study, it is proposed to test the feasibility, in terms of tolerability and efficacy of monotherapy with vinflunine in patients who, after completing the first-line cisplatin-based treatment for Transitional Cell Carcinoma of the Urothelial Tract (CCTU), have reached a stabilization or objective response. In order to have an adequate control group in the proposed design will be a phase II trial in which one group will receive standard management (follow-up until progression disease).

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Hospital General de Elda Virgen de la Salud, Elda, Alicante, Spain

ICO-Hospital Universitari Germans Trias i Pujol, Badalona, Barcelona, Spain

ICO-Hospital Duran i Reynals, L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Fundació Althaia, Manresa, Barcelona, Spain

Corporació Sanitaria Parc Taulí, Sabadell, Barcelona, Spain

Complejo Hosp. Univ. de Santiago de Compostela, Santiago de Compostela, Galicia, Spain

Hospital Universitario Fundación Alcorcón, Alcorcon, Madrid, Spain

H. del Mar (Fundació Institut Mar d´Investigacions Mèdiques - FIMIM), Barcelona, , Spain

H. Universitari Vall d'Hebrón, Barcelona, , Spain

Hospital Clínic i Provincial de Barcelona, Barcelona, , Spain

H. General Universitario de Ciudad Real, Ciudad Real, , Spain

Hospital General Universitario Gregorio Marañon, Madrid, , Spain

Hospital Clínico San Carlos, Madrid, , Spain

Hospital Universitario 12 de Octubre, Madrid, , Spain

Hospital Universitari Son Espases, Palma de Mallorca, , Spain

Clínica Universitaria de Navarra (CUN), Pamplona, , Spain

Complejo Hospitalario de Navarra, Pamplona, , Spain

H. Universitario Virgen de la Macarena, Sevilla, , Spain

H. Universitario Virgen del Rocío, Sevilla, , Spain

IVO, Valencia, , Spain

Contact Details

Name: Jesús García-Donas, MD

Affiliation: Hospital Universitario Fundación Alcorcón

Role: PRINCIPAL_INVESTIGATOR

Name: Albert Font, MD

Affiliation: ICO-Hospital Universitari Germans Trias i Pujol

Role: PRINCIPAL_INVESTIGATOR

Name: Joaquim Bellmunt, MD

Affiliation: H. del Mar - FIMIM (Fundació Institut Mar d´Investigacions Mèdiques)

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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