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FP7

EUROSARC Sintesi della relazione

Project ID: 278742
Finanziato nell'ambito di: FP7-HEALTH
Paese: France

Periodic Report Summary 1 - EUROSARC (European Clinical trials in Rare Sarcomas within an integrated translational trial network)

Project Context and Objectives:

Sarcomas are a rare and heterogenous group of malignant tumours, with an overall incidence of 6/100.000/year. Bone and soft tissue sarcomas encompass, according to the most recent World Health Organisation (WHO) classification, more than 50 different rare histotypes and more than 150 molecular subtypes. The incidence of most of them is often less than 0.5/100.0000/year, as shown recently within the Conticanet and EuroBoNeT FP6 Networks of Excellence epidemiological projects.

Due to the rarity of sarcomas, very few clinical trials or systemic treatments have been carried out in specific subtypes of the tumour. Furthermore, present treatment strategies in local phase are not adapted to histological or molecular subtypes. Nevertheless, sarcomas are very favourable models to develop novel agents targeting specific molecular alterations because these alterations are often well characterized. Their treatment now needs to be adapted to develop targeted therapies.

The goal of the euroSARC project is to address major academic questions arising in selected groups of soft tissue and bone sarcomas. To this aim, euroSARC comes in to establish new systemic treatment strategies and to set up innovative targeted therapies based on the scientific understanding of molecular alterations driving the tumours thereby developing paradigm changing clinical research. Translational research and facilitating cooperation on international level are also amongst the euroSARC projects objectives, but its main aim remains to further improve the duration of survival and the quality of life of patients. The euroSARC project aims to design, structure and implement 9 innovative investigator driven clinical trials of different scales, on a multinational level, evaluating novel local and systemic treatment strategies: a randomized preoperative radiotherapy trial in retroperitoneal sarcomas, a randomized neoadjuvant cytotoxic chemotherapy trial in localized high-risk soft tissue sarcomas, 6 trials exploring targeted therapies in rare sarcoma subtypes (Ewing sarcoma, chondrosarcoma, giant cell tumour of bone and osteosarcoma) in prospective randomized trials and in phase II proof of concept studies.

Coordinated by the Prof. Jean-Yves Blay (Université Claude Bernard Lyon 1), the euroSARC consortium gathers representatives of most European sarcoma groups and SME, all with proven track records of scientific and clinical excellence: Centre Anticancéreux Léon Bérard (CLB, FR), ACADEMISCH ZIEKENHUIS LEIDEN (LUMC, NL), Institut Gustave Roussy (IGR, FR), THE CHANCELLOR, MASTERS AND SCHOLARS OF THE UNIVERSITY OF OXFORD (UOXF, UK), FONDAZIONE IRCCS ISTITUTO NAZIONALE DEI TUMORI (INT, IT), ISTITUTO ORTOPEDICO RIZZOLI (IOR, IT), Institut Bergonié (Bergonié, FR), AZIENDA UNITA LOCALE SOCIO SANITARIA N 9 DI TREVISO (ULSS9, IT), FUNDACION DE INVESTIGACION DEL CANCER DE LA UNIVERSIDAD DE SALAMANCA (CIC, ES), MARIA SKLODOWSKA-CURIE MEMORIAL CANCER CENTER (MCMCC, PL), RUPRECHT-KARLS-UNIVERSITAET HEIDELBERG (UHEI, DE), EUROPEAN ORGANISATION FOR RESEARCH AND TREATMENT OF CANCER AISBL (EORTC, BE), Sarcoma Patients Euro Net (SPAEN, DE), THE UNIVERSITY OF BIRMINGHAM (UOB, UK), OXFORD GENE TECHNOLOGY (OPERATIONS) Ltd (OGT, UK), Lyon Ingénierie Projets (LIP, FR) and FUNDACION DE LA SOCIEDAD ESPANOLA DE LA ONCOLOGIA MEDICA (FSEOM, ES).

Project Results:
The achievements between December 2011 (M01) and May 2013 (M18) can be summarized as follows:

 Translational research
During this period, Standard Operating Procedures (SOPs) for molecular diagnosis in EuroBoNeT/Conticanet were reviewed and are available to all euroSARC consortium members. The consortium set up the translational research (TR) associated to retroperineal and localized high-risk soft tissue sarcomas. Furthermore, the translational research on Ewing sarcoma, osteosarcoma and chondrosarcoma is ongoing and is well on track. For giant cell tumour of the bone, the euroSARC consortium had to wait for formal approval of European Medicines Agency (EMA) and the pharmaceutical company, so no translational research was yet initiated.
Partners also improved virtual tumour banks developed by EuroBoNeT/Conticanet consortia in collaboration with the ENCCA network (http://www.encca.eu) and released an updated version.

 Status of the clinical trials
Retroperitoneal sarcoma
The randomized preoperative radiotherapy trial in retroperitoneal sarcomas trial protocol was approved. This study was set-up and initiated on December 2011. Up to date, 14 out of 35 sites were opened (in Italy, France, Germany, the UK, the Netherlands and Denmark) and 52 out of 256 patients were recruited. The activation of the countries and sites was performed under the coordination of the EORTC.

Localized high-risk soft tissue sarcoma
The phase III randomized study comprising standard versus histotype-tailored neo-adjuvant chemotherapy trial protocol was finalised and approved in many sites. The study is already active in all participating countries: Italy, Spain, Poland and France. During the M1 – M18 period, 136 patients were recruited.

Ewing sarcoma
Linsitinid in Ewings protocol was finalised (including statistical considerations) with the agreement of UOXF, EORTC and the pharmaceutical company. Patients’ information sheets and e-CRF were released. First patient will be recruited on August 2013.

Chondrosarcoma
The protocol and statistical design of the chondrosarcoma study are ready. However, the consortium is still waiting for the approval of the pharmaceutical company to launch the study.

Giant cell tumour of bone
GCTB project was postponed by industry. The consortium is now waiting for the final decision of the pharmaceutical company.

Osteosarcoma
The mifamurtide in Osteosarcoma study protocol (including statistical design) was developed and is now under approval. All documents will be available by September 2013.

All these tasks are performed by involving a patient association (SPAEN) as partner in the project.

Potential Impact:
The euroSARC main objective is to increase the duration of survival and the quality of life of sarcoma patients. The project will improve the routine management of rare tumours, molecular characterisation for individual patients as well as patient care and access to tailored medicine.

The euroSARC project will also enable:
• to standardize and organize the diagnostic procedures
• to develop and implement clinical trials testing novel neoadjuvant treatment options in randomized setting
• to develop a new methodology for performing efficiently clinical trials
• to progress towards an improved classification and nosology of rare tumors
• to include pharmacodynamic endpoints to demonstrate the specific mode of activity

In a broader perspective, the euroSARC project will likely also serve to other pathologies - and the close involvement of patients association all along the trials organisation and implementation process intends to give the European Union researchers a leading role worldwide for the development of novel treatment strategies in academic setting in sarcomas and therefore in rare cancers with the aim of expanding later this consortium worldwide for subsequent trials (especially in Asian countries and Russia).


List of Websites:

http://www.eurosarc.eu/

Informazioni correlate

Reported by

UNIVERSITE LYON 1 CLAUDE BERNARD

Argomenti

Life Sciences