PROMOTING AND DEVELOPING INNOVATIVE AND STRATEGIC CLINICAL RESEARCH TO IMPROVE THE TREATMENT OF PATIENTS WITH BONE AND SOFT TISSUE SARCOMAS

The Unicancer Sarcoma Group, a member of the INTERSARC cooperative intergroup, accredited by the INCa in 2013, was set up in 1999 on the basis of strong links with the GSF-GETO (French Sarcoma Group and Bone Tumour Study Group) and the SFCE (French Society for the Fight against Childhood and Adolescent Cancer and Leukaemia).

Since 1999, 13 studies have been initiated and conducted by the Unicancer Sarcoma Group, allowing the inclusion of more than 2000 patients. The most recent projects include translational research aimed at providing a better understanding and knowledge of biological mechanisms, as well as the characterisation of biomarkers potentially predictive of response to treatment.

The intergroup collaborates with health institutions in France and abroad.

The Unicancer Sarcoma Group develops innovative and high quality clinical and translational research to improve the diagnosis, management, prognosis and quality of life of children and adults with sarcomas . In addition, the Group engages a significant part of its efforts on pooling and harmonizing already existing databases for the promotion of data sharing which is of paramount importance in rare diseases

For many years, Unicancer has benefited from the support of the Ligue contre le Cancer to carry out this numerous research in sarcoma and in particular in paediatric sarcoma.

2 studies on recruitment

3 projects of data pooling/sharing

A network of more than 50 investigational centres in adult and paediatric oncology

National and International collaborations:

• INCa: Institut National du Cancer
• GSF-GETO : Groupe sarcome français et Groupe d’étude des tumeurs osseuses
• Go-AJA : Groupe d’onco-hématologie de l’adolescent et du jeune adulte
• SFCE : Société Française de la lutte contre les Cancers et les leucémies de l’Enfant et de l’adolescent
• GROUPOS : Comité os du GSF-GETO
• INTERSARC : Intergroupe coopérateur Sarcome
• EORTC : European Organisation for Research and Treatment of Cancer
• EuroEwing Consortium
• University of Chicago, USA (Pediatric Cancer Data Commons program)
• Associations de patients Info Sarcome, SOS Desmoïde

More than 2000 patients included

4 scientific publications in 2021

• REGOBONE
• SARCOME 13

INTERSARC is composed of 8 cooperative groups. A scientific committee has been establishing, with 8 members of the intergroup, each of the representative of a cooperative group: S Bonvalot, O Collard, N Gaspar, F Gouin, D Lacroix, E Lecointe, Al Martin, P Meeus. Coordination is ensured by Pr.Jean Yves Blay.

INTERSARC members meet three-monthly.

According to the functional charter, a process has been developed in INTERSARC to validate new project/trial: the project leader completes and submits to the coordinator a standardized synopsis of the project. The project is then discussed within the INTERSARC Scientific Committee for decision making.

Define the strategy of the Intergroup

• Propose and build prospective clinical trials & surveys or retrospective studies
• Validate the scientific value of the studies
• Promote data sharing by optimizing existing databases in France and joining international data collection initiatives
• Collaborate with international cooperative groups
• Conduct national and international clinical studies on Sarcomas.

Unicancer brings to InterSarc its expertise in the conduct of complex, national or international clinical trials, which can associate complex designs to the collection of serial biological samples.  Unicancer Sarcoma Group takes advantage of the existing infrastructure consisting in highly experienced operational staff, a central data base and a central biobank.

Chairperson of the Unicancer Sarcoma Group

The Unicancer Sarcoma Group is led by 2 coordinators:

•     coordinator for the adult population: Pr Jean-Yves Blay, Centre Léon Bérard, Lyon
•     coordinator for the paediatric population: Dr Nathalie Gaspar, Gustave Roussy, Villejuif.

SARCOME 12 – REGOBONE

This is a randomized phase II, placebo-controlled, multicenter study evaluating efficacy and safety of regorafenib in patients with metastatic bone sarcomas. This study has included more than 130 patients and is still recruiting.

SARCOME 13 – OS2016

This study aims to demonstrate that mifamurtide combined with standard post-operative chemotherapy improves event-free survival compared to chemotherapy alone for newly diagnosed high risk osteosarcoma patients (metastatic osteosarcoma at diagnosis or localised disease with poor histological response). This is a Multicentre, Randomised, Open-label, Phase 2 trial, currently recruiting.

SARCOME 14 – Boost Datas

Boost Datas is a national database aiming at pooling, structuring and sharing clinical, biological, imaging and transcriptomic/genomic data issued from terminated of currently on going national trials on osteosarcoma at diagnosis (OS2006, Sarcome13, MICCHADO) and relapse (OSII-TTP, MAPPYACTS, Regobone). The objective is to determine sub-classes of osteosarcomas underlined by different genetic clones and microenvironnement interactions, by integrated innovative techniques for analysis. Final aim is to propose adapted follow-up and specific treatments for each ostaosarcoma sub-classes.

According to the functional charter, a process has been developed in INTERSARC to validate new project/trial: the project leader completes and submits to the coordinator a standardized synopsis of the project. The project is then discussed within the INTERSARC Scientific Committee for decision making.

Anyone specialised in sarcoma can propose a study.

The criteria for having a project developped under the label of InterSarc are as follows:

• Adequacy of the inclusion criteria to each population : the aim is to promote the inclusion of pediatric patients and adolescent and Young adults in every INTERSARC trial.
• Patient involvement: opinions and recommendations of INTERSARC patients’ committees are required and considered for the development of all new trials.
• Biological/translational comprehensive objectives : this is a fundamental criteria for InterSarc who promotes an integrated research for the development of knowledge and the identification of predictive and prognostic biomarkers for treatment response and resistance.
• The medical, technical and financial feasibility