Informations générales (source: ClinicalTrials.gov)
Prognostic Value of the CINSARC (Complexity Index in Sarcoma) Signature and Correlation With Chemotherapy Efficacy in Soft-tissue Sarcomas. A Biomarker Study. (NEOSarcomics ) (NEOSarcomics)
Interventional
N/A
Institut Bergonié (Voir sur ClinicalTrials)
juin 2016
août 2027
29 juin 2024
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.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CLCC INSTITUT CURIE | Contact (sur clinicalTrials) | ||||
| CLCC INSTITUT GUSTAVE ROUSSY | Contact (sur clinicalTrials) | ||||
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre Georges François Leclerc - 21079 - Dijon Cedex - France | Nicolas ISAMBERT | Contact (sur clinicalTrials) | |||
| Centre Oscar Lambret - 59020 - Lille Cedex - France | Contact (sur clinicalTrials) | ||||
| Institut Bergonié - 33076 - Bordeaux - France | Antoine ITALIANO, MD,PhD | Contact (sur clinicalTrials) | |||
| Institut Claudius Regaud - IUCT-0 - 31052 - Toulouse Cedex 9 - France | Christine CHEVREAU, MD | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| AP-HM _ Hôpital de la Timone - 13385 - Marseille Cedex 05 - France | Florence DUFFAUD, MD, PhD | Contact (sur clinicalTrials) | |||
| Centre Léon Bérard - 69373 - Lyon Cedex 08 - France | Jean-Yves BLAY, MD, PhD | Contact (sur clinicalTrials) | |||
| Institut de Cancérologie de l'Ouest - 44805 - Nantes - France | Emmanuelle BOMPAS, MD | Contact (sur clinicalTrials) | |||
| Institut Paoli Calmettes - 13273 - Marseille Cedex 9 - France | François BERTUCCI, MD | Contact (sur clinicalTrials) | |||
Critères
Tous
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).
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).
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.