Evaluating the CINSARC biomarker in soft-tissue sarcomas and chemotherapy effectiveness

Prognostic Value of the CINSARC (Complexity Index in Sarcoma) Signature and Correlation With Chemotherapy Efficacy in Soft-tissue Sarcomas. A Biomarker Study. (NEOSarcomics )

This study is testing if a specific genetic marker can help predict how well chemotherapy will work for patients with non-metastatic soft-tissue sarcomas.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 205 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Institut Bergonié (other)
• Drugs / interventions: chemotherapy
• Locations: 10 sites (Bordeaux and 9 other locations)
• Trial ID: NCT02789384 on ClinicalTrials.gov

What this trial studies

This prospective observational biomarker study focuses on patients with non-metastatic soft-tissue sarcomas who are recommended for neoadjuvant chemotherapy. The study aims to validate the prognostic value of the CINSARC signature by correlating tumor responses to chemotherapy with the genetic profiles of the tumors. By identifying molecular predictive factors of chemotherapy sensitivity, the research seeks to improve management strategies for soft-tissue sarcoma patients in both adjuvant and metastatic settings. Archived tumor samples or biopsies will be utilized to gather necessary data for analysis.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed non-metastatic soft-tissue sarcomas who are eligible for neoadjuvant chemotherapy.

Not a fit: Patients with metastatic soft-tissue sarcomas or those who have received prior chemotherapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more personalized and effective treatment strategies for patients with soft-tissue sarcomas.

How similar studies have performed: Other studies have shown promise in using biomarkers for predicting chemotherapy efficacy, making this approach both relevant and potentially impactful.

Eligibility criteria

Inclusion Criteria:

1. 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,
2. Available archived frozen tumor tissue sample or patient consenting to undergo a biopsy of the tumour for research purpose,
3. 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,
4. Age ≥ 18 years,
5. Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 1,
6. Measurable disease according to RECIST v1.1 outside any previously irradiated field,
7. 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,
8. 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,
9. Voluntarily signed and dated written informed consents prior to any study specific procedure,
10. 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:

1. Pathological diagnosis different from a soft-tissue sarcoma,
2. Histological subtypes: well-differentiated liposarcoma, alveolar soft-part sarcoma, dermatofibrosarcoma protuberans, clear-cell sarcoma, rhabdomyosarcoma,
3. Previous treatment for the sarcoma,
4. Contra-indication precluding the administration of chemotherapy as assessed by the investigator,
5. Participation to a study involving a medical or therapeutic intervention in the last 30 days,
6. Previous enrolment in the present study,
7. Pregnant or breast feeding women,
8. Patient unable to follow and comply with the study procedures because of any geographical, social or psychological reasons.

Where this trial is running

Bordeaux and 9 other locations

• Institut Bergonié — Bordeaux, France (RECRUITING)
• Centre Georges François Leclerc — Dijon, France (RECRUITING)
• Centre Oscar Lambret — Lille, France (NOT_YET_RECRUITING)
• Centre Léon Bérard — Lyon, France (RECRUITING)
• Institut Paoli Calmettes — Marseille, France (RECRUITING)
• AP-HM _ Hôpital de la Timone — Marseille, France (RECRUITING)
• Institut de Cancérologie de l'Ouest — Nantes, France (RECRUITING)
• Institut Curie — Paris, France (NOT_YET_RECRUITING)
• Institut Claudius Regaud - IUCT-0 — Toulouse, France (RECRUITING)
• Institut Gustave Roussy — Villejuif, France (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Antoine ITALIANO, MD,PhD

Conditions: Soft-tissue Sarcomas, soft-tissue sarcomas, CINSARC, biomarker, efficacy, pronostic