Procedure/Surgery: Procedure/Surgery: Newly obtained biopsy if applicable and Blood samples collection.
For each patient:
* Frozen and paraffin embedded tumor material (archival or new biopsy) will be obtained for genetic profiling
* Blood samples will be obtained for genetic profiling and assessment of markers.
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.
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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