This is a prospective observational biomarker study including patients with non-metastatic, soft-tissue sarcomas (STS) for whom neoadjuvant chemotherapy is considered as the best option by the multidisciplinary sarcoma team of one of the participating centers.
Histologically confirmed soft-tissue sarcoma by central review, except if the diagnosis was already confirmed by the RRePS (Réseau de Référence en Pathologie des Sarcomes et des Viscères) Network,
Available archived frozen tumor tissue sample or patient consenting to undergo a biopsy of the tumour for research purpose,
Non-metastatic disease, for which the use of chemotherapy to "downstage" the sarcoma prior to surgery, is assumed to result in better local tumor control by the multidisciplinary sarcoma team of one of the French reference centers involved in this study,
Age ≥ 18 years,
Pathological diagnosis different from a soft-tissue sarcoma,
Histological subtypes: well-differentiated liposarcoma, alveolar soft-part sarcoma, dermatofibrosarcoma protuberans, clear-cell sarcoma, rhabdomyosarcoma,
Previous treatment for the sarcoma,
Contra-indication precluding the administration of chemotherapy as assessed by the investigator,
Single group
Procedure/Surgery
Other interventionProcedure/Surgery: Newly obtained biopsy if applicable and Blood samples collection. For each patient: * Frozen and paraffin embedded tumor material (archival or new biopsy) will be obtained for genetic profiling * Blood samples will be obtained for genetic profiling and assessment of markers. The classification as CINSARC will be performed for each patient. Patients should be treated by neoadjuvant anthracycline-based chemotherapy. Chemotherapy regimen must contain at least doxorubicin (dose range: 60 -75 mg/m²) and ifosfamide (dose range: 2.5-3g/m²) to be delivered on a 21-days cycle basis up to 6 cycles prior surgery. After neoadjuvant chemotherapy completion, patients will be treated by surgery followed or not by radiotherapy. All patients should be managed according to the usual medical practices.
Assessment of antitumor activity of neoadjuvant anthracycline based chemotherapy. Efficacy will be defined based on complete response, partial response and stable disease observed during treatment following RECIST v1.1 criteria.
Efficacy of neoadjuvant anthracycline based chemotherapy in terms of proportion of tumour cells identified on the surgical specimen
Association of the CINSARC signature and histological response based on the proportion of tumour cells identified on the surgical specimen
Patient's classification by CINSARC signature. Patients will be classified as either low risk CINSARC or high risk
Metastasis-free survial is defined following recent guidelines for the definition of survival endpoints in sarcoma trials (Bellera et al. Annals Oncol 2014.
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Institut Bergonié
Lead sponsor
National Cancer Institute, France
Collaborator
Ministry of Health, France
Collaborator
