El Grupo Español de Investigación en Sarcomas( http://www.grupogeis.org/ ) lleva a cabo un Ensayo Clinico de Fase II en 20 de los Mejores Hospitales Españoles bajo la Supervisión de Oncologos Especalistas en dicha Enfermedad :*.- Sponsors and Collaborators : Grupo Espanol de Investigacion en Sarcomas
*.- Investigators :
* Principal Investigator: Javier Martin Broto, PhM GEIS
* Principal Investigator: Andres Poveda, Ph.M. GEIS
* Xavier García del Muro, Ph.M.
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*.- Purpose :
The proposed investigation intends to explore if the combination of trabectedin and doxorubicin in the first line of treatment of advanced sarcomas obtains better results than doxorubicin monotherapy. This proposal arises from the need to bring to the first line of treatment of advanced STS agents that have shown activity in second line. The goal is to improve available standard treatments. Tumors in patients not previously exposed to chemotherapy have not been selected in their biological behavior and they are the best scenario to test antitumor activity of a new anticancer drug.
The combination of drugs with different mechanisms of action may be a clear advantage to obtain better results and potential synergy. On the other hand, the toxicity profiles of both study drugs are different and worsening or summative of adverse effects is not expected.
To determine the efficacy of the combination of trabectedin and doxorubicin in comparison with doxorubicin alone in patients with advanced non operable and/or metastatic Soft Tissue Sarcomas (STS).
*.- Condition Intervention Phase
Sarcoma
* Drug: Doxorubicin
* Drug: Trabectedin plus Doxorubicin
* Phase II
*.- Study Type: Interventional
*.-Study Design: Allocation: Randomized
*.-Control: Active Control
*.-Endpoint Classification: Safety/Efficacy Study
*.-Intervention Model: Parallel Assignment
*.- Open Label
*.-Primary Purpose: Treatment
*.- Official Title: RANDOMIZED, OPEN, MULTICENTER, PROSPECTIVE, PHASE II CLINICAL TRIAL OF DOXORUBICIN vs. TRABECTEDIN PLUS DOXORUBICIN IN THE FIRST LINE TREATMENT OF PATIENTS WITH ADVANCED NON OPERABLE AND/OR METASTATIC SOFT TISSUE SARCOMAS .
*.- Locations : Spain .
Barcelona
* Ico Hospitalet Recruiting
L'Hospitalet, Barcelona, Spain
Principal Investigator: Xavier García del Muro, Ph.M.
Spain
* ICO Badalona Recruiting
Badalona, Spain
Principal Investigator: Carmen Balañá, Ph.M.
* H. Clinic Barcelona Recruiting
Barcelona, Spain
Principal Investigator: Joan Maurel Santasusana, Phm
* H. Sant Pau Recruiting
Barcelona, Spain
Principal Investigator: Antonio López Pousa, Ph.M.
* H. Provincial Castellón Recruiting
Castellón, Spain
Principal Investigator: Ramón De las Peñas, Ph.M
* ICO Girona Recruiting
Girona, Spain
Principal Investigator: Jordi Rubió, Ph.M.
* H. Xeral Cies Recruiting
Lugo, Spain
Principal Investigator: Juan A Carrasco, Ph.M.
* H. Clínico. San Carlos Recruiting
Madrid, Spain
Principal Investigator: Antonio Casado, Ph.M.
* Clinica Puerta Hierro Recruiting
Madrid, Spain
Principal Investigator: Ricardo Cubedo, Ph.M.
* H.U. Gregorio Marañon Recruiting
Madrid, Spain
Principal Investigator: Rosa Álvarez, Ph.M.
* H. U. La Paz Recruiting
Madrid, Spain
Principal Investigator: Andres Redondo, Ph. M
* H.U. Ramon Y Cajal Recruiting
Madrid, Spain
Principal Investigator: María Ángeles Vaz, Ph.M.
* H.U. Clinico de Malaga Recruiting
Málaga, Spain
Principal Investigator: Isabel Sevilla, Ph.M.
* H. de Navarra Recruiting
Navarra, Spain
Principal Investigator: Nuria Laínez, Ph.M.
* H. C. Asturias Recruiting
Oviedo, Spain
Principal Investigator: Joaquin Fra, Ph.M.
* H. Son Dureta Recruiting
Palma de Mallorca, Spain
Principal Investigator: Javier Martín Broto, Ph.M.
* H. Univ. Canarias Recruiting
Santa Cruz de Tenerife, Spain
Principal Investigator: Josefina Cruz, Ph.M.
* H.U. Virgen Del Rocio Recruiting
Sevilla, Spain
Principal Investigator: Flor Oncala, Ph.M.
* Instituto Valenciano de Oncología Recruiting
Valencia, Spain
Principal Investigator: Andres Poveda, Ph.M.
* H. Miguel Servet Recruiting
Zaragoza, Spain
Principal Investigator: Javier Martínez Trufero, Ph.M.
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