CINSARC Signature and Correlation With Hemotherapy Efficacy in Soft-tissue Sarcomas. A Biomarker Study.
- Conditions
- Soft-tissue Sarcomas
- Interventions
- Other: Procedure/Surgery
- Registration Number
- NCT02789384
- Lead Sponsor
- Institut Bergonié
- Brief 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.
- Detailed 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
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 205
- 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,
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Procedure/Surgery Procedure/Surgery Newly obtained biopsy if applicable and blood samples collection according to the usual medical practices.
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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 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
Trial Locations
- Locations (10)
Institut Bergonié
🇫🇷Bordeaux, France
Institut Claudius Regaud - IUCT-0
🇫🇷Toulouse Cedex 9, France
Centre Oscar Lambret
🇫🇷Lille Cedex, France
Centre Georges François Leclerc
🇫🇷Dijon Cedex, France
Institut de Cancérologie de l'Ouest
🇫🇷Nantes, France
Institut Paoli Calmettes
🇫🇷Marseille Cedex 9, France
Institut Curie
🇫🇷Paris Cedex, France
Institut Gustave Roussy
🇫🇷Villejuif Cedex, France
AP-HM _ Hôpital de la Timone
🇫🇷Marseille Cedex 05, France
Centre Léon Bérard
🇫🇷Lyon Cedex 08, France