CINSARC Signature and Correlation With Hemotherapy Efficacy in Soft-tissue Sarcomas. A Biomarker Study. (NEOSarcomics)

  • STATUS
    Recruiting
  • End date
    Oct 9, 2025
  • participants needed
    205
  • sponsor
    Institut Bergonié
Updated on 27 January 2022
measurable disease
carcinoma
doxorubicin
cancer chemotherapy
ifosfamide

Summary

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.

Description

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

Details
Condition Soft-tissue Sarcomas
Treatment Procedure/Surgery
Clinical Study IdentifierNCT02789384
SponsorInstitut Bergonié
Last Modified on27 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Histologically confirmed soft-tissue sarcoma by central review, except if the diagnosis was already confirmed by the RRePS (Rseau de Rfrence en Pathologie des Sarcomes et des Viscres) 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
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 1
Measurable disease according to RECIST v1.1 outside any previously irradiated field
Neoadjuvant anthracycline-based chemotherapy proposed as the best option by the multidisciplinary sarcoma team of one of the French reference centers involved in this study
No prior or concurrent malignant disease diagnosed or treated in the last 2 years except for adequately treated in situ carcinoma of the cervix, basal or squamous skin cell carcinoma, or in situ transitional bladder cell carcinoma
Voluntarily signed and dated written informed consents prior to any study specific procedure
Patients with a social security in compliance with the French Law relating to biomedical research (Article 1121-11 of French Public Health Code)

Exclusion Criteria

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
Participation to a study involving a medical or therapeutic intervention in the last 30 days
Previous enrolment in the present study
Pregnant or breast feeding women
Patient unable to follow and comply with the study procedures because of any geographical, social or psychological reasons
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