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| Name | Class |
|---|---|
| National Cancer Institute, France | OTHER_GOV |
| Ministry of Health, France | OTHER_GOV |
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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.
Even when retrospective statistical identification for a biomarker has been achieved, the ultimate proof of its usefulness in the clinic still requires prospective evidence. Our prospective study aims to validate the prognosis value of the CINSARC signature in a prospective way. Moreover, the neoadjuvant setting is an ideal one to identify molecular predictive factors of sensitivity to chemotherapy by correlating tumor response with genetic profile of STS. Moreover, molecular profiling of treatment-refractory tumor cells may reveal alterations that are associated with drug resistance, metastatic recurrence and disease progression. The identifications of such factors in the neoadjuvant setting may help to improve the management of STS patients in the adjuvant and metastatic settings
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Procedure/Surgery | Experimental | Newly obtained biopsy if applicable and blood samples collection according to the usual medical practices. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Procedure/Surgery | Other | Procedure/Surgery: Newly obtained biopsy if applicable and Blood samples collection. For each patient:
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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | participants will be followed for the duration of treatment, an expected average of 6-months |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of neoadjuvant anthracycline based chemotherapy in terms of proportion of tumour cells identified on the surgical specimen | an expected average of 6 months | |
| Association of the CINSARC signature and histological response based on the proportion of tumour cells identified on the surgical specimen |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Antoine ITALIANO, MD,PhD | Contact | a.italiano@bordeaux.unicancer.fr | ||
| Simone MATHOULIN-PELISSIER, MD,PhD | Contact | s.mathoulin@bordeaux.unicancer.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institut Bergonié | Recruiting | Bordeaux | 33076 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39444039 | Derived | Guegan JP, El Ghazzi N, Vibert J, Rey C, Vanhersecke L, Coindre JM, Toulmonde M, Spalato Ceruso M, Peyraud F, Bessede A, Italiano A. Predictive value of tumor microenvironment on pathologic response to neoadjuvant chemotherapy in patients with undifferentiated pleomorphic sarcomas. J Hematol Oncol. 2024 Oct 23;17(1):100. doi: 10.1186/s13045-024-01614-w. |
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| ID | Term |
|---|---|
| D012509 | Sarcoma |
| ID | Term |
|---|---|
| D018204 | Neoplasms, Connective and Soft Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| an expected average of 6 months |
| Patient's classification by CINSARC signature. Patients will be classified as either low risk CINSARC or high risk | 6 months |
| Metastasis-free survial is defined following recent guidelines for the definition of survival endpoints in sarcoma trials (Bellera et al. Annals Oncol 2014. | 3 years |
| 3 -year Overall Survial (OS) defined as the time from study treatment initiation to death (of any cause). | 3 years |
| Histological response is defined using both 3 histological parameters: proportion of recognizable tumor cells, fibrosis and necrosis in the surgical specimen. | an expected average of 6 months |
| Identification of molecular mechanisms involved in intrinsic resistance to chemotherapy by correlating the transcriptome data with response to chemotherapy. | an expected average of 6 months |
| Adverse events related to the biopsy procedure will be graded using the common toxicity criteria from the NCI v4.0. | during 7 days after biopsy |
| Centre Georges François Leclerc | Recruiting | Dijon | 21079 | France |
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| Centre Oscar Lambret | Not yet recruiting | Lille | 59020 | France |
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| Centre Léon Bérard | Recruiting | Lyon | 69373 | France |
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| Institut Paoli Calmettes | Recruiting | Marseille | 13273 | France |
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| AP-HM _ Hôpital de la Timone | Recruiting | Marseille | 13385 | France |
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| Institut de Cancérologie de l'Ouest | Recruiting | Nantes | 44805 | France |
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| Institut Curie | Not yet recruiting | Paris | 75005 | France |
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| Institut Claudius Regaud - IUCT-0 | Recruiting | Toulouse | 31052 | France |
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| Institut Gustave Roussy | Not yet recruiting | Villejuif | 94805 | France |
|