Interest of Peri Operative CHemotherapy In Patients With CINSARC High-risk Localized Soft Tissue Sarcoma

Phase III, multicenter, randomized open-label and comparative study designed to demonstrate whether adding 4 cycles of peri-operative doxorubicin-based chemotherapy improves metastasis-free survival as compared with standard management in patients with resectable STS, considered as high-risk according to CINSARC (Complexity Index in SARComas) signature. After signed informed consent, patients considered as eligible to CHIC-STS study by the investigator will be enrolled in the study and a molecular screening will be performed (600 patients will be screened). Patients considered as low-risk ac

Trial Details

NCT ID
NCT04307277
Phase
PHASE3
Sponsor
Institut Claudius Regaud
Status
RECRUITING
Cancer Type
Sarcoma
Interventions
  • Standard of care + chemotherapy
  • Standard of care
Locations (sample)
  • Besançon, France|47.24878,6.01815
  • Caen, France|49.18585,-0.35912
  • Clermont-Ferrand, France|45.77969,3.08682
  • Dijon, France|47.31344,5.01391
  • Limoges, France|45.83362,1.24759

Key Eligibility Criteria

  • Diagnosis of soft-tissue sarcoma, histologically confirmed by RRePS (Réseau de Référence en Pathologie des Sarcomes et des Viscères) network
  • According to FNCLCC grading system, grade 1, 2 or 3 tumors
  • Resectable and localized disease after appropriate extension work-up (including at least a chest-CT)
  • 6 weeks or less between surgical excision and inclusion (if performed before inclusion)

For full eligibility, visit ClinicalTrials.gov.

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