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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Institut Bergonié
  Bordeaux, France Recruiting
• Centre Georges François Leclerc
  Dijon, France 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

Study contacts

• Study coordinator: Antoine ITALIANO, MD,PhD
• Email: a.italiano@bordeaux.unicancer.fr

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.