Yondelis Fase III . Localized High-Risk Soft Tissue Sarcomas Of The Extremities And Trunk Wall In Adults: An Integrating Approach Comprising Standard Vs Histotype-Tailored Neoadjuvant Chemotherapy .

ClinicalTrials Identifier: NCT01710176


Updated: 2012_10_18


Brief summary :


This is a randomized Phase III clinical trial in the setting of localized high-risk soft tissue sarcomas (STS). This study will compare a standard neoadjuvant chemotherapy with epirubicin plus ifosfamide versus a histology-driven chemotherapy, i.e. a chemotherapy tailored to the specific histology within the family of adult STS. Chemotherapy will be administered for 3 cycles. There will be five histological groups (representing 80% of STS), as follows: leiomyosarcoma, myxoid liposarcoma with hypercellularity (round cell MLPS), synovial sarcoma, malignant peripheral nerve sheath tumor (MPNST) and undifferentiated pleomorphic sarcoma. The histology-driven chemotherapy for these groups will be, respectively, gemcitabine plus dacarbazine, trabectedin, high-dose ifosfamide, ifosfamide plus etoposide, gemcitabine plus docetaxel. Other histological groups will also be included and registered, but treated only by standard chemotherapy. Patients who have already undergone definitive surgery will receive treatment post-operatively and patients needing a re-excision after inadequate surgery will be treated as patients in the two groups, but of course will not be evaluable for response. A centralized pathological review will be performed. Radiological response will be evaluated according to RECIST and to Choi criteria. Pathological response will also be recorded.

The endpoint will be disease-free survival (DFS) and, secondarily, overall survival (OS) of patients receiving standard chemotherapy versus those receiving histotype-tailored chemotherapy. Additional aims will be to compare the probability of response of standard vs histotype-tailored chemotherapy and to determine the radiological and pathological response with standard chemotherapy vs tailored chemotherapy in each different histological group. Another aim will be to validate the response (both radiological and pathological) to preoperative chemotherapy as a surrogate endpoint for DFS and OS.

Three hundred patients will be randomized over a 3-years period, from a pool of 400-450 registered patients.

Translational research will be performed. Areas of research will include identification and validation of the potential predictive markers for each histological subgroups.

The study is designed to verify the statistical hypothesis that histotype-tailored approach is associated, overall, with a 30% reduction in the hazard of relapse. However, in each different histological group, the effect of histotype-tailored chemotherapy, as compared to standard chemotherapy, can be different. To address this weakness an orthogonal study of response to chemotherapy as a surrogate of DFS and OS has been introduced into the trial. This study intends to extensively investigate the response (radiological and pathological) to preoperative chemotherapy and to validate it as a surrogate endpoint by showing that it correlates with disease free survival and overall survival.

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Recruitment Information :


Status : Recruiting

Start date  : 2011-06

Primary completion date : 2013-06 (Anticipated)

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 Administrative Data :

Organization name : Italian Sarcoma Group

Organization study ID : ISG-STS 10-01

Sponsor  : Italian Sarcoma Group

Collaborator : GROUPE SARCOMES FRANÇAIS

Collaborator : Grupo Espanol de Investigacion en Sarcomas

Health Authority :  Italy: Ethics Committee

´El futuro en el cáncer pasa por tratamientos personalizados que usan fármacos más caros´ .

Alfredo Carrato habla sobre los retos del tratamiento del cáncer, que requieren alejarse de las soluciones homogéneas: "Las personas no son iguales entre sí y los tumores tampoco" .

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Las terapias personalizas son sinónimo de más caras, ¿choca esto con la época de crisis y recortes en la que nos encontramos?


„Efectivamente. Todos estos fármacos de los que hablo son de reciente adquisición y tienen un precio superior al de los clásicos, así que encarecen el producto final. Pero suponen una ventaja para los pacientes, ya que viven más tiempo, tienen una calidad de vida superior y se evitan complicaciones como ingresos, transfusiones, operaciones... Factores que se pagan por otra parte. No solo hay que tener el foco en el fármaco, hay que tener una perspectiva global y pensar que lo que te gastas en el medicamento te lo ahorras en otras cosas como hospitalizaciones. Por otro lado, ayudas a que la persona siga trabajando, a que en lugar de vivir doce meses viva cinco años, a que esté con su familia...

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